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Stem cells are unspecialized cells that can develop into any type of cell in the human body. So far, however, scientists only partially understand how the body controls the fate of these all-rounders, and what factors decide whether a stem cell will differentiate, for example, into a blood, liver or nerve cell. Researchers from the Luxembourg Centre for Systems Biomedicine (LCSB) of the University of Luxembourg and an international team have now identified an ingenious mechanism by which the body orchestrates the regeneration of red and white blood cells from progenitor cells. "This finding can help us to improve stem cell therapy in future," says Dr. Alexander Skupin, head of the "Integrative Cell Signalling" group of LCSB. The LCSB team has published its results in the scientific journal PLOS Biology.
Although all cells in an organism carry the same genetic blueprints -- the same DNA -- some of them act as blood or bone cells, for example, while others function as nerve or skin cells. Researchers already understand quite well how individual cells work. But how an organism is able to create such a diversity of cells from the same genetic template and how it manages to relocate them to wherever they are needed in the body is still largely unknown.
In order to learn more about this process, Alexander Skupin and his team treated blood stem cells from mice with growth hormones and then watched closely how these progenitor cells behaved during their differentiation into white or red blood cells. The researchers observed that the cells' transformation does not occur in linear, targeted fashion, but rather more opportunistically. Each progenitor cell adapts to the needs of its environment and integrates itself into the body where new cells are needed. "So, it is not as though the cell takes a ticket at the beginning of its differentiation and then travels straight to its destination. Rather, it gets off frequently to look around and see which line is best to take," Alexander Skupin explains. By this clever mechanism, a multicellular organism can adapt the regrowth of new cells to its current needs. "Before progenitor cells differentiate once and for all, they first lose their stem cell character and then check, as it were, which cell line is currently in demand. Only then do they develop into the cell type that best suits their characteristics and which prevails in their environment," Alexander Skupin says.
The researcher likens this step to a game of roulette, where the different types of cells can be thought of as the differently numbered slots in the roulette wheel that catch the ball. "When the cells lose their stem cell character, they are quasi thrown into the roulette wheel, where they first bounce around aimlessly. Only when they have found the right environment do the cells then drop into that niche -- like the roulette ball falling into a numbered slot -- and differentiate definitively." This way, the body can orchestrate its cell regeneration and at the same time prevent stem cells from being misdirected too early. "Even if a cell takes a wrong turn, it is ultimately sorted out again if its characteristics are unsuitable for the niche, or slot, it has landed in," says Skupin.
With their study, Alexander Skupin and his team have shown for the first time that a progenitor cell's fate is not clearly predetermined and does not follow a straight line. "This observation contradicts the current doctrine that stem cells are programmed to follow a certain lineage from the beginning," Alexander Skupin says. The researcher is furthermore convinced that the processes are similar for other progenitor cells. "In the lab, we have observed the same differentiation pattern in so-called iPS cells, or induced pluripotent stem cells, which can transform into many different types of cells."
This knowledge can help the researchers to improve the effectiveness of therapies in future. Stem cell therapy involves administering a patient his or her own body's stem cells in order to replace other cells that have died as a result of an affliction such as Parkinson's disease. While this promising treatment method has been intensively researched over many years, there has so far been only limited practical success in endogenous stem cell therapy. It is also highly controversial, since it is frequently accompanied by severe side effects and it cannot be ruled out that some cells might degenerate and lead to cancer. "Because we now have a better understanding of how the body influences the direction in which stem cells differentiate, we can hopefully control this process better in future," Alexander Skupin concludes.
Story Source:
Materials provided by University of Luxembourg. Note: Content may be edited for style and length.
https://www.sciencedaily.com/releases/2017/03/170315094508.htm
Mending broken hearts with cardiomyocyte molds
Date:March 13, 2018 Source:Michigan Technological University Summary:Whether caused by an undetected birth defect or by a heart attack (myocardial infarction), when a heart sustains damage, it can be difficult to repair. New research shows how cardiomyocytes grown in a heart-like environment mature more quickly, have improved functionality and are less likely to be rejected by patients' bodies.
Whether caused by an undetected birth defect or by a heart attack (myocardial infarction), when a heart sustains damage, it can be difficult to repair.
2.5 billion. That's approximately the number of times the human heart beats in 70 years. And sometimes during the course of its unrelenting contractions and relaxations, the heart muscle can no longer bear the strain.
If heart muscle cells -- cardiomyocytes -- could be repaired by cells taken from one's own body, the patient's recovery improves. But manufacturing heart cells requires an exacting process tailored specifically to an individual. Laid out in a new article published today in Advanced Functional Materials, a team of researchers at Michigan Technological University in collaboration with Harvard Medical School, shows how cardiomyocytes grown in a heart-like environment mature more quickly, have improved functionality and are less likely to be rejected by patients' bodies.
Pluripotent Stem Cells
Many people with heart injuries from heart attacks or birth defects
could benefit from the "self-therapeutic" process of injecting healthy cells into the damaged heart muscle. Labs use induced pluripotent stem cells, also known as master cells, which using biochemical cues can be "programmed" to become any type of cell, whether for the heart muscle or otherwise. Yet current processes result in underdeveloped cells.
To date, manufacturing cardiomyocytes has occurred in two-dimensional settings (essentially, petri dishes). But the growth environment plays a large role in the ways the cells develop. Thus, simulating the actual heart environment -- with lots of pressure and specific forces acting on the growing cells -- could lead to more robust cardiomyocytes.
"Unfortunately stem cell therapeutics don't have high success rates partly because the cells are not mature and fully functional. The maturation and functionality are essential," says Parisa Pour Shahid Saeed Abadi, assistant professor of mechanical engineering, whose work in creating heart cell growth environments is detailed in the new article "Engineering Mature Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes using Substrates with Multi-Scale Topography."
Mimicking the Natural Heart Environment
Abadi and her coauthors have created three-dimensional substrates -- essentially, molds -- that recreate the environment in which heart cells grow inside the human body. Biomechanical properties the substrates induce include pressure and stiffness.
"The mechanical properties of substrates play an important role in the cell behavior because the mechanical cues that cells sense in the actual (heart) environment is unique," Abadi says. "We are using biochemical and biomechanical cues to enhance the differentiation and maturation. If we don't take advantage of the physical cues and only rely on chemical cues, the process suffers from low efficiency and batch-to-batch inconsistency."
Using photolithography and re-flow processing, Abadi's substrates are patterned at the micron and submicron levels, approximating the natural physical forces cells experience. Photolithography uses ultra-violet light to remove portions of polydimethylsiloxane (PDMS) substrate to mold it into cylindrical shapes.
Additional micro-patterning of the substrate changes the cytoskeleton in the cell and the shape of the nucleus, which cause the genes in the cell to change. As the cardiomyocytes mature, they beat stronger and resemble the cells found in natural, mature heart muscle.
"On day one we start seeing the effect of the substrate on the morphology of the cells," Abadi says.
Next Steps
Abadi's lab, which is partly funded by the American Heart Association, continues to improve the substrate preparation methods. As cardiomyocytes need to communicate with each other during their growth, Abadi also plans to stimulate electrical conductivity between cells. Translational studies in animals are the next step for the research.
"My lab works at the interface of materials, mechanics and medicine," says Abadi, who came to Michigan Tech in 2017 following a National Institutes of Health post-doctoral fellowship at Harvard Medical School's Brigham and Women's Hospital.
Abadi notes that her lab relies on the interdisciplinary backgrounds of its undergraduates, graduate students and post-doctoral researchers, combining different knowledge bases to solve complex questions of fabricating better nanomaterials for medical applications that cannot be tackled from one discipline alone.
"I pick problems I can solve with the knowledge of mechanical engineering and nanomaterials," she says. "I use microfabrication and nanofabrication techniques to tackle problems that are challenging for biologists or clinicians to address."
To mend broken hearts, Abadi and her engineering team have learned that strong cardiomyocytes grow better under pressure.
Story Source:
Materials provided by Michigan Technological University. Original written by Kelley Christensen. Note: Content may be edited for style and length.
Journal Reference:
1.Parisa P. S. S. Abadi, Jessica C. Garbern, Shahed Behzadi, Michael J. Hill, Jason S. Tresback, Tiam Heydari, Mohammad Reza Ejtehadi, Nafis Ahmed, Elizabeth Copley, Haniyeh Aghaverdi, Richard T. Lee, Omid C. Farokhzad and Morteza Mahmoudi. Engineering of Mature Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes Using Substrates with Multiscale Topography. Advanced Functional Materials, 2018; DOI: 10.1002/adfm.201707378
https://www.sciencedaily.com/releases/2018/03/180313093056.htm
“Right-to-try,” the controversial plan to help the terminally ill that just failed in the House, explained
Experts worry the legislation is unnecessary and carries more risk than reward.
By Dylan Scott@dylanlscottdylan.scott@vox.com Updated Mar 13, 2018, 7:30pm EDT
In a surprising twist, the House failed to pass a bill on Tuesday that would have given terminally ill patients more opportunities to try experimental treatments — but that experts worried would actually expose them to more risk.
The legislation is the brainchild of the so-called “right-to-try” movement. The gist of the movement’s mission is that terminally ill patients should be given wide latitude to try out unproven treatments if they have exhausted all their other options.
But it came up short in a House vote on Tuesday evening. Republicans tried to use a procedural shortcut to pass the legislation, which required two-thirds of lawmakers to support it. It failed, with 259 votes in favor and 140 votes against, almost all of them Democrats, plus two Republicans: Erik Paulsen of Minnesota and Patrick Meehan of Pennsylvania. (That’s 65 percent — just shy of the threshold.)
More than 30 states have passed a “right-to-try” bill, often favored by more libertarian-minded people. Supporters portray it as a humanitarian exercise for people with no other hope that removes the risk of a bureaucracy getting in their way. It has been a priority for the Trump White House: President Trump urged Congress to pass a bill during his State of the Union speech, and Vice President Mike Pence has been outspoken in favor of it.
“It’s about restoring hope and giving patients with life threatening diseases a fighting chance,” Pence tweeted earlier this year.
But skeptics have two big objections: First, that these bills are unnecessary because the Food and Drug Administration already does a good job letting terminally ill people access experimental treatments. And second, that the only thing these bills achieve is opening up patients to more risk. The bill is opposed by prominent patient groups, like the American Cancer Society and the National Organization for Rare Disorders.
Alison Bateman-House, who studies medical ethics at the New York University Langone Medical Center, walked me through the complexities last year.
"We have a functioning expanded access procedure through the FDA," she told me in August when the Senate passed its version of “right-to-try.”
The status quo versus “right-to-try,” explained
It might help to understand how the FDA’s current program works and what it would look like under "right-to-try."
Under the FDA's current policy, patients who want to try a treatment that has cleared only the first round of clinical trials must:
1.Find a doctor who will agree to try the therapy.
2.Contact the drug company to ask permission to test the treatment.
3.With that permission, fill out paperwork for the FDA and send it in.
4.If the FDA doesn't object, the patient can try the treatment.
5.A board at the institution where the treatment is taking place must also be notified and grant approval.
6.The patient must grant consent and may have to pay money for the treatment.
Under a "right-to-try" bill, the process is almost exactly the same, except the FDA is removed from the equation:
1.Find a doctor who will agree to try the therapy.
2.Contact the drug company to ask permission to test the treatment.
3.With that permission, the patient can try the treatment.
4.A board at the institution where the treatment is taking place must also be notified and grant approval.
5.The patient must grant consent and may have to pay money for the treatment.
The House legislation includes a few other notable conditions for patients, doctors and pharmaceutical companies using “right-to-try”:
•Drug companies must notify the FDA when a patient is giving an unapproved treatment under “right-to-try.”
•Drugmakers must also report any adverse effects that a patient using a “right-to-try” drug experiences.
•The clinical outcomes from patients using a drug under “right-to-try” cannot be used for determining whether the drug is eventually approved for broader use by the FDA.
(Please note that pharmaceutical policy is hopelessly complex, so these are the broad strokes. Also, state laws differ, so how they would interact with any new federal law could differ as well.)
Why experts are dubious about “right-to-try” bills
The core issue with the legislation, from its critics’ point of view, is that there really isn’t a problem here to solve.
Based on the available data, the FDA already approves 90 percent or more of the requests it receives to try unproven therapies, and the agency usually responds in a matter of days, Bateman-House told me. There isn’t much evidence of a pandemic of terminally ill patients being blocked from testing treatments because of bureaucratic snags.
Second, in both cases, the real hurdle is getting approval from the drug company to test a treatment. That would still be true under a “right-to-try” regime.
“You have a right to ask a drug company if you can try,” Bateman-House said. “The only thing that disappears is that FDA step.”
And therein lies the concern of Bateman-House and others. The existing program, which would still be in place even if “right-to-try” becomes law, allows the FDA to be an independent arbiter.
Without that federal oversight, Bateman-House believes there is a greater risk of fraud and abuse at the expense of patients.
“By getting rid of that, what you’re doing is you’re relying on a doctor and a quote-unquote drug company,” she explained, “but there are no specifications about that relationship.”
“For all I know, the doctor works for the drug company, owns the drug company, owns stock in the drug company, or the drug company gives the doctor kickbacks,” she continued.
The House bill does differ slightly from the Senate version. A smaller number of patients would be eligible to utilize “right-to-try”: They must be terminally ill, have exhausted all their other treatment options, be ineligible for other clinical trials, and be expected to die within a matter of months.
But that doesn’t change the foundational issues that opponents like Bateman-House have.
“This version of the bill is an improvement over the last, but it doesn’t change the fact that the purpose of this bill is to sever access to investigational drugs from FDA review and approval,” she told me this week in an email.
She noted, too, that while the current population that’s eligible for “right-to-try” is so narrow as to be nonexistent, now that the procedure exists, it could be expanded to include more and more patients. In Texas, for example, “right-to-try” supporters are attempting to expand the program from terminally ill patients to chronically ill ones.
This is the bottom line, based on my conversations with Bateman-House about this issue over the past few months:
•The FDA already has a functioning procedure for experimental treatments.
•The “right-to-try” bill actually leaves that procedure in place.
•All the bill does is potentially create an alternative pathway for patients.
•We don’t even know if patients will take it.
•If they do, because the FDA is no longer a part of the process, there is a greater risk of fraud and abuse.
“This area is already replete with confusion, and we don’t need any more confusion,” Bateman-House told me. “I think patients are going to end up losing.”
https://www.vox.com/policy-and-politics/2018/3/13/17113690/right-to-try-laws-congress
'Stem cells could touch just about every area of medicine,' experts say.
By Stacey Colino, Contributor Oct. 4, 2017, at 12:24 p.m.
U.S. News & World Report
Stem Cells May Hold the Fix
Researchers are investigating growing new body parts and healing old ones via patients' own stem cells.(Getty Images)
Believe it or not, the cure to what ails you could already be inside you. Welcome to the dawning world of stem cell therapy, in which researchers are exploring the possibilities of growing new body parts and healing old ones by using patients' own stem cells. The idea is that these unspecialized cells (which can also be harvested from a donor) can be induced to develop into heart or lung or brain cells, say, and be injected to replace those damaged by disease or injury. While bone marrow stem cell therapies for certain cancers date back several decades, the approach is now being used or studied for a wide array of diseases and injuries.
FDA Approves Gene-Altering Leukemia Drug
"Stem cells could be the new antibiotics," says Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine. "When you put the pieces of the puzzle together, stem cells could touch just about every area of medicine."
For the record: The cells Hare is talking about are not taken from embryos, a practice mired in controversy. They come from an adult's body tissue, usually the bone marrow, fat or skin. These "master cells" operate as a kind of internal repair system because they can replicate in a continuous fashion to replenish other cells or morph into cells with specialized functions.
Recently, headlines have cast a shadow over stem cell therapy by drawing attention to private clinics offering unproven interventions – and sometimes unfortunate outcomes. For example, an article in the New England Journal of Medicine this spring described three women who experienced vision loss after injections of stem cells derived from their fat tissue for age-related macular degeneration. At this point, most stem cell therapies are experimental, and patients should be looking for rigorous research. But "if you take stem cells from a patient and re-inject them back into the patient, there's no regulation of that," explains Donald Zack, director of the Johns Hopkins Center for Stem Cell and Ocular Regenerative Medicine, which is preparing to test whether such therapies can treat conditions like glaucoma, macular degeneration and retinitis pigmentosa.
Among the most established therapies to date are those for musculoskeletal problems such as arthritis of the knees, hips and shoulders; meniscus tears; and Achilles tendonitis. Stem cells from a patient's bone marrow or belly fat are injected into an injured joint in an outpatient procedure that lasts about 45 minutes. "It's not a panacea, but it offers another opportunity to delay a joint replacement," says Laith Jazrawi, chief of the division of sports medicine at NYU Langone Medical Center. Delay is good "because there's a longevity issue with joint replacement."
"I didn't want that type of surgery," says Mike Barnet, 62, an avid cyclist and squash player from Margate, New Jersey, who'd been advised to have both knees replaced for bone-on-bone arthritis and a torn meniscus in his right one. He contacted Jazrawi, and a few weeks after an injection into his right knee of stem cells from his pelvic bone, the knee was free of pain and swelling. That was two and a half years ago. "I might need a knee replacement down the road," says Barnet, "but I'm hoping that this will be a long-term fix."
At the Cleveland Clinic, researchers are conducting trials to see if stem cells can address stress urinary incontinence. "We're trying to regenerate the muscle cells, so the sphincter muscle can close and prevent leakage," explains Courtenay Moore, a physician at the Clinic's Glickman Urological Institute. Early findings have shown that after a single injection into the urethra, over two-thirds of women improved by more than 50 percent, compared to a 75 to 80 percent cure rate for surgery. "Three of the women I've injected run on the treadmill at my gym," Moore reports. "And they run faster than me!"
Precisely how stem cell therapies work is still being uncovered. What's emerging is a realization that "they teach the body to heal from within," explains Atta Behfar, a cardiologist and director of the cardiac regenerative medicine program at the Mayo Clinic. Stem cells delivered into a heart injured by a heart attack don't "serve as the brick and mortar to repair the heart," he says. "It's the proteins and other substances they secrete that tell your body to heal."
Good Doctoring Will Mean Keeping Patients…
Research on stroke, for example, has suggested that when stem cells are injected into the brain, they set off a release of factors that contribute to the recovery process, notes Lawrence Wechsler, chairman of the department of neurology at the University of Pittsburgh School of Medicine. (Mayo Clinic researchers in Florida are investigating whether the healing power might extend to brain cancer. In rodents, the effects of stem cells range from a shrinking of the tumors to complete remission. This is noteworthy because few drugs can cross the blood-brain barrier. Stem cells injected into the carotid artery get through, "act as Trojan horses and begin to kill cancer cells," says Alfredo Quinones-Hinojosa, chair of neurosurgery and director of Mayo Clinic's Brain Tumor Stem Cell Research Laboratory in Jacksonville.)
Not surprisingly, results aren't always dramatic. That was the case for Kate Brock of Gambrills, Maryland, 57, whose 2010 stroke left her right side semiparalyzed. In 2013, she had stem cells injected into her brain at Pittsburgh. She gained mobility and strength in her arm, but it didn't last. "The only thing that really changed a lot," says Brock, is that "my legs work better together."
Besides targeted injections, intravenous infusion of stem cells from a healthy donor is being studied as a way to deal with the frailty associated with aging. Preliminary findings from the University of Miami indicate that the therapy significantly reduces systemic inflammation, improves immune function, and boosts physical performance. "Look, I don't want to exaggerate these effects – I can't leap over buildings," says Phillip George, a retired plastic surgeon whose aches and pains, especially after playing golf, led him to participate in the frailty program. "But I have more energy and I feel much more comfortable." Six weeks after treatment, he performed dramatically better on pulmonary function tests and increased his distance on a six-minute walking test. His need for anti-inflammatory drugs is down by 90 percent.
With the field still developing, it's vital that people investigate a treatment's safety and efficacy for their condition. "There's a lot of excitement about stem cells," says Zack, "but we have to do this in a smart way." What that means, he says, is that a treatment should be based on science, not simply hope or beliefs.
https://www.usnews.com/news/healthcare-of-tomorrow/articles/2017-10-04/stem-cells-may-hold-the-fix
Earnings release Wednesday, March, 21st 2018
https://www.marketbeat.com/stocks/OTCMKTS/USRM/
US Stem Cell is scheduled to release their next quarterly earnings announcement on Wednesday, March, 21st 2018.
'Stem cells could touch just about every area of medicine,' experts say.
By Stacey Colino, Contributor Oct. 4, 2017, at 12:24 p.m.
U.S. News & World Report
Stem Cells May Hold the Fix
Researchers are investigating growing new body parts and healing old ones via patients' own stem cells.(Getty Images)
Believe it or not, the cure to what ails you could already be inside you. Welcome to the dawning world of stem cell therapy, in which researchers are exploring the possibilities of growing new body parts and healing old ones by using patients' own stem cells. The idea is that these unspecialized cells (which can also be harvested from a donor) can be induced to develop into heart or lung or brain cells, say, and be injected to replace those damaged by disease or injury. While bone marrow stem cell therapies for certain cancers date back several decades, the approach is now being used or studied for a wide array of diseases and injuries.
FDA Approves Gene-Altering Leukemia Drug
"Stem cells could be the new antibiotics," says Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine. "When you put the pieces of the puzzle together, stem cells could touch just about every area of medicine."
For the record: The cells Hare is talking about are not taken from embryos, a practice mired in controversy. They come from an adult's body tissue, usually the bone marrow, fat or skin. These "master cells" operate as a kind of internal repair system because they can replicate in a continuous fashion to replenish other cells or morph into cells with specialized functions.
Recently, headlines have cast a shadow over stem cell therapy by drawing attention to private clinics offering unproven interventions – and sometimes unfortunate outcomes. For example, an article in the New England Journal of Medicine this spring described three women who experienced vision loss after injections of stem cells derived from their fat tissue for age-related macular degeneration. At this point, most stem cell therapies are experimental, and patients should be looking for rigorous research. But "if you take stem cells from a patient and re-inject them back into the patient, there's no regulation of that," explains Donald Zack, director of the Johns Hopkins Center for Stem Cell and Ocular Regenerative Medicine, which is preparing to test whether such therapies can treat conditions like glaucoma, macular degeneration and retinitis pigmentosa.
Among the most established therapies to date are those for musculoskeletal problems such as arthritis of the knees, hips and shoulders; meniscus tears; and Achilles tendonitis. Stem cells from a patient's bone marrow or belly fat are injected into an injured joint in an outpatient procedure that lasts about 45 minutes. "It's not a panacea, but it offers another opportunity to delay a joint replacement," says Laith Jazrawi, chief of the division of sports medicine at NYU Langone Medical Center. Delay is good "because there's a longevity issue with joint replacement."
"I didn't want that type of surgery," says Mike Barnet, 62, an avid cyclist and squash player from Margate, New Jersey, who'd been advised to have both knees replaced for bone-on-bone arthritis and a torn meniscus in his right one. He contacted Jazrawi, and a few weeks after an injection into his right knee of stem cells from his pelvic bone, the knee was free of pain and swelling. That was two and a half years ago. "I might need a knee replacement down the road," says Barnet, "but I'm hoping that this will be a long-term fix."
At the Cleveland Clinic, researchers are conducting trials to see if stem cells can address stress urinary incontinence. "We're trying to regenerate the muscle cells, so the sphincter muscle can close and prevent leakage," explains Courtenay Moore, a physician at the Clinic's Glickman Urological Institute. Early findings have shown that after a single injection into the urethra, over two-thirds of women improved by more than 50 percent, compared to a 75 to 80 percent cure rate for surgery. "Three of the women I've injected run on the treadmill at my gym," Moore reports. "And they run faster than me!"
Precisely how stem cell therapies work is still being uncovered. What's emerging is a realization that "they teach the body to heal from within," explains Atta Behfar, a cardiologist and director of the cardiac regenerative medicine program at the Mayo Clinic. Stem cells delivered into a heart injured by a heart attack don't "serve as the brick and mortar to repair the heart," he says. "It's the proteins and other substances they secrete that tell your body to heal."
Good Doctoring Will Mean Keeping Patients…
Research on stroke, for example, has suggested that when stem cells are injected into the brain, they set off a release of factors that contribute to the recovery process, notes Lawrence Wechsler, chairman of the department of neurology at the University of Pittsburgh School of Medicine. (Mayo Clinic researchers in Florida are investigating whether the healing power might extend to brain cancer. In rodents, the effects of stem cells range from a shrinking of the tumors to complete remission. This is noteworthy because few drugs can cross the blood-brain barrier. Stem cells injected into the carotid artery get through, "act as Trojan horses and begin to kill cancer cells," says Alfredo Quinones-Hinojosa, chair of neurosurgery and director of Mayo Clinic's Brain Tumor Stem Cell Research Laboratory in Jacksonville.)
Not surprisingly, results aren't always dramatic. That was the case for Kate Brock of Gambrills, Maryland, 57, whose 2010 stroke left her right side semiparalyzed. In 2013, she had stem cells injected into her brain at Pittsburgh. She gained mobility and strength in her arm, but it didn't last. "The only thing that really changed a lot," says Brock, is that "my legs work better together."
Besides targeted injections, intravenous infusion of stem cells from a healthy donor is being studied as a way to deal with the frailty associated with aging. Preliminary findings from the University of Miami indicate that the therapy significantly reduces systemic inflammation, improves immune function, and boosts physical performance. "Look, I don't want to exaggerate these effects – I can't leap over buildings," says Phillip George, a retired plastic surgeon whose aches and pains, especially after playing golf, led him to participate in the frailty program. "But I have more energy and I feel much more comfortable." Six weeks after treatment, he performed dramatically better on pulmonary function tests and increased his distance on a six-minute walking test. His need for anti-inflammatory drugs is down by 90 percent.
With the field still developing, it's vital that people investigate a treatment's safety and efficacy for their condition. "There's a lot of excitement about stem cells," says Zack, "but we have to do this in a smart way." What that means, he says, is that a treatment should be based on science, not simply hope or beliefs.
https://www.usnews.com/news/healthcare-of-tomorrow/articles/2017-10-04/stem-cells-may-hold-the-fix
Stem Cell Awareness Day: Past, Present, Future
October 11, 2017 / Kevin McCormack
In 2008, the then California Governor Arnold Schwarzenegger declared Sept. 25 to be Stem Cell Awareness Day. In the proclamation he said, ”The discoveries being made today in our Golden State will have a great impact on many around the world for generations to come.”
In the years since, we have moved steadily towards turning those words into reality and using Stem Cell Awareness Day, now celebrated on the second Wednesday in October, as a symbol of the progress being made, not just in California but around the world.
Yesterday, for example, at a public event at UC Davis in Sacramento, Dr. Jan Nolta told an audience of patients, patient advocates, researchers and stem cell supporters that “we are part of a new era in medicine, one where it will one day be routine for prescriptions to be written for stem cell treatments for many different diseases.”
Those sentiments were echoed by Jonathan Thomas, Chair of the CIRM Board, who said:
“This is a time of truly extraodinary medical science. We are lucky because, in our lifetime, we are going to see many of the biggest maladies plaguing people cured, in part because of developments in regenerative medicine. Every week you read about extraordinary developments in medicine and often those are here in California.”
In the early years Stem Cell Awareness Day was very much a creation of CIRM. We worked closely with our partners in academia and industry to host or stage events around the state. In 2009 for example, more than 40 CIRM grantees went to high schools in California, talking about stem cell research to more than 3,000 students. We also coordinated with researchers in Canada and Australia to create a global community of supporters.
We even hosted a poetry competition. No, really, we did. So, clearly not every idea we had back then was a winner.
These days CIRM doesn’t play as prominent a role in organizing these events for a very simple reason. We don’t have to. They have become such a popular part of the scientific calendar that individual institutions and schools organize their own events, without any pushing or prodding from us (though we are always happy to help when asked).
At UC Irvine this afternoon there is an Open House where you can take a self-guided tour of the facility, meet some of the scientists and watch lab demonstrations.
This weekend the UC Berkeley’s Student Society of Stem Cell Research (SSSCR) is hosting its 5th annual Stem Cell Conference: Culturing a Stem Cell Community. This conference aims to bring together different aspects of stem cell research, from science to advocacy, to demonstrate the growth and success of the field. You can RSVP on Eventbrite (tickets cost a small fee of $7 or $12 including lunch to support the cost of the SSSCR conference)
The Gladstone Institutes in San Francisco just posted two new videos to its YouTube site:
•The Basics of Stem Cells
•How Are Stem Cells Being Used in Research?
In the early days of CIRM, Stem Cell Awareness Day was a valuable way for us to talk directly to the people of California – the ones who created CIRM. We felt it was important to let them know how their money was being spend and about the progress being made in stem cell research. And in the early years that progress was slower than all of us would have liked. Today, it’s a very different situation with CIRM now having funded 40 projects in clinical trials (and a goal of funding dozens more in the coming years) and with advances being made every day. We still reach out to our supporters and the patient advocate community but now we do it year round through our blog, social media and public events like the one yesterday at UC Davis.
While we are not as “hands on” as we were in the past we are still more than happy to provide tools for groups or organizations who want to hold their own stem cell awareness event – and it doesn’t have to be on October 11th, it can be any day of the year. Visit our Education Portal, Patient Resources page and video archive for various teaching tools.
https://blog.cirm.ca.gov/2017/10/11/stem-cell-awareness-day-past-present-future/
(CNN)Just months after the US Food and Drug Administration announced efforts to crack down on stem cell clinics touting unapproved therapies, the agency now plans to help expedite the development of stem cell therapies proved to be safe and effective.
Dr. Scott Gottlieb, the FDA commissioner, and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, co-authored a new paper detailing the delicate balance between safety and innovation when it comes to the possibilities of using stem cells in medicine.
"Our aim is to refashion our traditional tools for regulation to meet the challenges and opportunities presented by such highly innovative products as cell-based regenerative medicine," they wrote in the paper, published Thursday in the New England Journal of Medicine. Divisions run deep over how to regulate stem cell clinics.
Stem cells have the potential to develop into many cell types in the body. Some studies suggest that stem cells may help the nearly blind to see and could reverse signs of aging. Research has even explored using stem cells to create red blood cells to replenish blood shortages during emergencies.
"However, despite the increasingly widespread use of stem cells in techniques being labeled as regenerative medicine, clinical benefit has not been clearly shown in most instances," Gottlieb and Marks wrote.
The FDA hopes to change that, while continuing efforts to regulate the industry.
'A sweet spot of stem cell oversight'
"This more reflects an update from the FDA on where their thinking stands on stem cells. I don't see it as backing down from the hoped-for stepping up of FDA oversight of clinics," said Paul Knoepfler, professor of cell biology and human anatomy at the University of California, Davis School of Medicine, who wrote a blog post about the new paper.
"The FDA seems to be saying they want to find a sweet spot of stem cell oversight where they encourage innovation by good citizens and yet also carefully regulate this sphere as well as encouraging those interested in transplanting stem cells into patients to work with the FDA," he said.
Stem cell study offers hope for ALS
Knoepfler co-authored a paper, published in the journal Cell Stem Cell in 2016, that found unapproved stem cell interventions being marketed at 570 clinics across the US. "Hot spot" cities where there were clusters of clinics included Beverly Hills, California; New York; San Antonio; Los Angeles; Austin, Texas; Scottsdale, Arizona, and Phoenix.
Although Gottlieb and Marks didn't mention clinics in their paper, they noted that facilitating the availability of safe and effective therapies was part of the FDA's oversight of regenerative medicine products, including new stem cell therapies.
The FDA will provide tools to encourage individual or small groups of physicians to collaborate in support of the development of a stem cell or other regenerative medicine product, they wrote.
A milestone in stem cell research
A milestone in stem cell research
Gottlieb and Marks also said the FDA is encouraging investigators who are involved in such innovative product development to engage in dialogue with the agency early on in the research process.
"It feels like the FDA leadership is in essence telling them, 'Do the right thing, and we'll help you with a trial, even if you aren't a big university or company,' " Knoepfler said. "It's reassuring to see though that the FDA still emphasizes it is crucial to have data and follow the rules."
The FDA held a Grand Rounds webcast on Thursday detailing how its scientists are examining strategies and methods to predict the reliability of how certain cell-based therapies will perform in humans.
The ability to make such predictions could be a big step toward getting safe and effective FDA-approved treatments to patients in the future.
Predicting the future
For many investigational stem cell-based products, it remains unclear whether the measurements currently used to characterize products will predict their clinical effectiveness, according to the FDA.
As of now, stem cell-based products submitted to the FDA in clinical trial proposals are characterized using a small number of cell surface markers and simple measures of cell product activity -- but is that enough to truly predict clinical outcomes?
Stem Cells Fast Facts
Answering that question has become one of many focuses of the FDA's Multipotent Stromal Cell Consortium, a large team of scientists studying adult multipotent stromal cells. These are stem cells that can differentiate into a variety of cell types and could contribute to tissue repair or help replace, restore or regenerate other parts of the body.
Steven Bauer, chief of the cellular and tissues therapy branch in the Center for Biologics Evaluation and Research, gave the keynote presentation at Thursday's Grand Rounds and focused on how, when multipotent stromal cells are studied for use as therapies, predictability is key.
"We can use some of this information to help generate standards in this field," he said. "There is a tremendous amount of interest now in developing standards that will facilitate the development of regenerative medicine and products."
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All in all, "combined with the publication today of New England Journal of Medicine article, the FDA wants to assure that developers of regenerative medicine therapies understand the regulatory pathways that are available," the agency said in a written statement emailed to CNN by a FDA spokesperson.
"The FDA is committed to ensuring that patients have access to safe and effective regenerative medicine products as efficiently as possible. We are also committed to making sure we take action against products being unlawfully marketed that pose a potential significant risk to their safety," the statement said.
"The agency has adopted a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA's authorities and enforcement priorities. This risk-based approach allows product developers time to engage with the FDA, to determine if they need to submit a marketing authorization application and, if so, submit their application to the FDA for approval," the statement said.
Why Doctors Are Pushing Back
By Alexandra Sifferlin
February 5, 2018
Doctors and medical ethicists are criticizing a bill supported by President Donald Trump that would allow people with fatal illnesses to have access to drugs not yet approved by federal authorities.
“Right to Try” is a policy that Trump mentioned during his State of the Union Address on Jan. 30. “People who are terminally ill should not have to go from country to country to seek a cure — I want to give them a chance right here at home,” he said. “It is time for the Congress to give these wonderful Americans the ‘right to try.'”
Right-to-try laws have passed in some 38 states. While no one wants to argue against giving potentially beneficial drugs to people who need them, not everyone in the medical community is convinced a national right-to-try policy—which has been introduced in the House—will ultimately make life better for patients. The bill for the federal law was passed by Senate in August by unanimous consent.
For a drug to be approved for use in the United States, it must undergo several rounds of clinical testing, a process that can take several years. The U.S. Food and Drug Administration (FDA)—the agency that oversees that approval process—does already have a system in place, often referred to as compassionate use, for getting unapproved drugs to people who are out of other options. Physicians can submit an Emergency Investigational New Drug (EIND) application to the agency if their patient has no other treatment options. With FDA permission and drug company willingness, a patient can try that treatment.
One of the biggest concerns with the federal right-to-try bill is that the FDA would be cut out of the loop. The bill would allow patients and their doctors to bypass the FDA process and work solely with drug companies for access to unapproved drugs that have undergone at least basic safety testing. The federal bill would also prevent doctors and drug companies from being held liable should something go wrong, and bar the FDA from using data on negative outcomes from right-to-try cases to impact the approval of a drug unless that data is critical to assessing the drug’s safety.
“The proposed legislation is a thinly veiled attempt to dismantle the FDA, which could take us back a hundred years or more,” says Dr. Steffanie Strathdee, the associate dean of global health science at the University of California, San Diego (UCSD) who requested an EIND for her husband in recent years. “Dying patients and their families are vulnerable; we could become victims to the likes of snake oil salesmen offering ‘treatments’ that could kill rather than cure. Treatments that work need to be monitored so their success can push forward randomized clinical trials that will decide if they work on a broader scale. And we need to know when treatments don’t work, so that the deaths of these patients are not in vain and that their failures aren’t repeated.”
A letter drafted and circulated by medical experts, which currently has more than 300 signatures from ethicists and physicians, argues that weakening the oversight of the FDA through the right-to-try law could ultimately be dangerous. The signed letter will be sent to the House Committee on Energy and Commerce on Monday. “Expanded access can be improved, but the right to try approach is misguided and would likely do more harm than good,” the letter reads. “This legislation sells vulnerable patients and families false hope at the expense of weakening the FDA’s critical role in making sure that all Americans can have confidence in the safety and effectiveness of our medical products.”
The FDA’s drug approval procedures were put into place in 1962 after women in Europe who were taking the drug thalidomide gave birth to babies with birth defects. The drug, which was marketed as a treatment for morning sickness and as a sleeping pill, was not approved for use in the U.S., but the tragedy helped spur Congress to pass a law that would require drug-makers to prove both safety and effectiveness.
As the letter authors point out, the FDA currently approves 99% of the patient requests for expanded access that it receives. “Because the FDA is not the obstacle to patient access to investigational drugs and plays a vital role in ensuring proper patient safeguards are in place, we implore the Committee to not pass legislation that would remove the FDA from the initial authorization process for accessing an investigational therapy outside of a clinical trial,” the letter reads.
The Goldwater Institute, a libertarian think tank, is one of the biggest supporters of right-to-try laws. The institute created a model bill that many states have used for their own right-to-try laws. “Ultimately the way we feel about all of this is it’s a matter of time. The genie is sort of out of the bottle,” said Starlee Coleman, the institute’s chief policy adviser, to Politico. “Patients have too much information now. They know when drugs in trials are working because they are connecting now more than they ever have been before. Maybe people who don’t want this will be able to stem the tide for a little while, but there will be something that comes later.” The federal policy has also received significant support from Freedom Partners, a network that supports the political initiatives of Charles and David Koch and the billionaire brothers’ political allies. (Time Inc., TIME’s parent company, was recently acquired by Meredith Corp. in a deal partially financed by Koch Equity Development, a subsidiary of Koch Industries Inc.) The group argues that even though the FDA grants the vast majority of compassionate use requests, it only received 1,757 requests in 2016, which the group says is small compared to the number of people who could potentially benefit.
Proponents of right-to-try legislation argue that it will cut down on the time it takes for a drug to go through the FDA for compassionate use. But UCSD’s Strathdee disagrees. In 2015 Strathdee’s husband contracted a drug-resistant infection that wasn’t responding to treatment. Strathdee and her husband’s medical team submitted an EIND to the FDA to request access to phage therapy, a treatment that is not approved for widespread use.
“In our case, the FDA official involved was far from obstructionist; she helped connect us to U.S. research teams we were unaware of, who agreed to make their experimental treatment available to us,” says Strathdee. “But the FDA was also careful. They required documentation to show that safety concerns had been considered and minimized to the extent possible.” This was vital, says Strathdee, since the proposed cure for her husband’s infection was derived from sewage. If improperly purified, the treatment could have caused septic shock and killed him.
The House Committee on Energy and Commerce is currently considering the federal right-to-try bill, and held a hearing about the policy in 2017. “Chairman [Greg] Walden is dedicated to ensuring patients have access to potentially lifesaving treatment while also preserving FDA’s vital oversight authority,” said a committee spokesperson in an email to TIME. “Having held a hearing last year, the committee continues to engage with patients, members, and advocates to advance fair policy that helps patients understand the full benefit of access to investigational drugs and therapies. While we don’t have a scheduling announcement at this time, Chairman Walden looks forward to continuing to work with the administration to get these reforms over the finish line for patients.”
As Politico reports, the Goldwater Institute says it does not want to get rid of the FDA, but it wants to call out the agency’s flaws, arguing that the review process for drug approval is expensive and long and that if it was easier, drugs would be less costly.
“In our view, the system is under-funded,” says Strathdee. “But it is not broken.”
http://time.com/5132892/right-to-try-bill-terminal-illness/
House Rejects Bill to Give Patients a ‘Right to Try’ Experimental Drugs
By ROBERT PEARMARCH 13, 2018
The House bill was considered under special fast-track procedures that required a two-thirds majority for passage, and it fell short. When the roll was called, 259 members supported the bill, and 140 opposed it. Credit Erin Schaff for The New York Times
WASHINGTON — In a surprising rebuff to President Trump and Republican leaders, the House derailed a bill on Tuesday that would have given patients with terminal illnesses a right to try unproven experimental treatments.
The bill was considered under special fast-track procedures that required a two-thirds majority for passage, and it fell short. When the roll was called, 259 House members supported the bill, and 140 opposed it.
Most of the opposition came from Democrats, who said the bill gave false hope to patients and could actually endanger people dying of incurable diseases, because it would undermine protections provided by the Food and Drug Administration.
“By defeating this bill tonight, we protected patients and supported F.D.A.’s continued role in approving experimental treatments that may help save a patient’s life,” said Representative Frank Pallone Jr. of New Jersey, the senior Democrat on the Energy and Commerce Committee. “This bill should have never been on the House floor in the first place since it was only introduced today.”
Republican leaders rushed the bill to the floor using a procedure normally reserved for uncontroversial legislation. But the bill ignited passions among supporters and critics.
The Senate passed a similar bill last year, and Mr. Trump supported the legislation.
The House Republican leader, Kevin McCarthy of California, said the bill was not dead. “We will try again, pass legislation and bring hope to those whose only desire is the right to try to live,” he said.
The bill could be brought up again under rules that allow passage with a simple majority.
Going into the debate on Tuesday, supporters of the bill expressed confidence that it would win approval.
“Our bill will give some relief to terminally ill patients who have no further options left to extend their lives,” said Representative Andy Biggs, a freshman Republican from Arizona, where a state right-to-try measure won 78 percent of the vote in a 2014 referendum. “All Americans have the right and freedom to try to save their lives.”
But many doctors and advocates for patients oppose the legislation.
“Supporters of this legislation talk as if effective treatments are being withheld from patients,” said Dr. Robert M. Califf, who was the commissioner of the Food and Drug Administration under President Barack Obama. “The vast majority of experimental therapies are toxic or ineffective. The only way we find out is through controlled studies where we measure the effects.”
In a letter to House leaders, more than 75 patient advocacy groups, including the lobbying arm of the American Cancer Society, opposed the bill.
The American Medical Association said it “does not believe that the bill will substantially improve patient access to investigational therapies.” And the American Society of Clinical Oncology, representing cancer doctors, said the bill “could do more harm than good for patients with life-threatening illnesses” because it would remove the Food and Drug Administration from the evaluation of the risks and potential benefits of some treatments.
Drug companies can already provide experimental medicines to patients outside clinical trials under a program known as expanded access or compassionate use. The F.D.A. says it approves about 99 percent of compassionate use requests. In emergencies or other urgent cases, the agency says, it approves requests for the use of experimental medicines within hours or days of being contacted by a doctor.
Representative Jan Schakowsky, Democrat of Illinois, said the bill would have created “a dangerous back door around the F.D.A. approval process.”
Vice President Mike Pence, who signed a right-to-try bill in 2015 as the governor of Indiana, pushed for the federal legislation.
Mr. Trump endorsed the idea in his State of the Union address in January. “People who are terminally ill should not have to go from country to country to seek a cure,” he said. “I want to give them a chance right here at home. It’s time for Congress to give these wonderful, incredible Americans the right to try.”
The drug industry was uncharacteristically quiet. The main lobbies for the industry — the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization — said they had not taken a formal position on the legislation.
The drive for right-to-try legislation was spearheaded by the Goldwater Institute, a public policy organization that advocates free markets and limited government.
Starlee Coleman, a policy adviser at the institute, said 38 states had adopted right-to-try laws, often with broad bipartisan support.
The House and Senate bills would establish a new pathway providing access to unapproved prescription drugs for certain patients who had exhausted other treatment options. Under the Senate bill, patients with “a life-threatening disease or condition” could obtain unapproved drugs, but eligibility under the House bill was more narrowly defined.
To qualify under the House bill, a patient would have to have some kind of terminal illness: a condition that is likely to cause death “within a matter of months” or “irreversible morbidity that is likely to lead to severely premature death.”
The patient would have to provide informed consent in writing. The manufacturer would have to notify the federal government within seven business days of providing the drug to a doctor for use by a patient, and the doctor must immediately report any “serious adverse events” to the drugmaker.
If patients take an experimental drug under the right-to-try legislation and if it proves unhelpful, the F.D.A. could not use the data to “delay or adversely affect” federal approval of the drug — unless the information was “critical to determining the safety” of the medicine.
The bill would also shield pharmaceutical companies, doctors and hospitals from some of the legal risks of providing drugs that have not been approved. Doctors and hospitals would generally be protected unless they engaged in gross negligence or willful, reckless or criminal misconduct, or they intentionally harmed a patient.
Nothing in the bill would require drug companies to provide experimental drugs to patients who want them, and companies turn down requests for various reasons. In some cases, they have only a limited supply of a product, which they want to use in clinical trials.
But some patients could benefit. “These are real people facing their mortality with no hope,” said Senator Ron Johnson, Republican of Wisconsin, the author of the bill passed by the Senate in August.
https://www.nytimes.com/2018/03/13/us/politics/house-rejects-right-to-try-bill.html
Someone dumped 1 million shares in 5 minutes. Brought the price down 20%.
Degenerative Disc Patients Significantly Improve with USRM’s Adipocell TM Chief Scientific Officer to Present Data at IFATS
Posted by U.S. Stem Cell, Inc
MIAMI, FL –Nov. 28, 2017 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today announced Chief Science Officer Dr. Kristin Comella will present clinical data demonstrating safety and efficacy of its proprietary Adipocell TM therapy in treating degenerative disc disease — a condition that affects more than 65 million Americans annually 1 — at the Annual Meeting for International Federation for Adipose Therapeutics and Science (IFATS).
Dr. Comella, who is a global leader in the development of revolutionary holistic stem cell therapies, will discuss her paper “Effects of the Intradiscal Implantation of Stromal Vascular Fraction Plus Platelet Rich Plasma in Patients With Degenerative Disc Disease,” on Thursday, November 30, 5:30 p.m., at the Lowes Hotel Miami Beach. Dr.
Comella’s presentation will also be live streamed at www.facebook.com/comella.stem.cell/.
The study, which included 15 patients with degenerative disc disease, featured the use of USRM’s proprietary Adipocell TM therapy following a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue. Adipocell TM kits and enzyme were used to separate and isolate a patient’s own stromal vascular fraction (SVF) which was then delivered into the disc of patients. Patients were then monitored for 6 months for adverse events, range of motion, visual analog scale (VAS), present pain intensity (PPI), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Dallas Pain Questionnaire and Short Form (SF)-12 scores. Safety events were also monitored, for a 12-month period.
The procedure demonstrated a strong safety profile with no severe adverse events (SAEs) or complications linked to the therapy they received, and no incidences of infection. Patients who participated in this study experienced statistically significant improvements in several parameters including flexion, pain ratings, VAS, PPI, and short form questionnaires. In addition, both ODI and BDI data was trending positive and a majority of patients reported improvements in their Dallas Pain Questionnaire scores. More importantly, patients overall were pleased with treatment results.
“We are seeing so many advancements in regenerative therapy as a result of the application of stem cells from adipose tissue, and the possibilities are endless,” said Dr. Comella, who co-authored the study along with two colleagues. “We are at a time in history where the potential for effective, regenerative medicine from autologous, stem cell therapy is exploding. At USRM, we are pioneering these new therapies for patients and we continue to publish first in man studies like this one.”
IFATS is a non-profit scientific society currently dedicated to scientific areas of interest related to facilitating the development of treatments for excess body fat, the generation of new fat tissue for reconstruction after cancer or birth-related defects and the use of adipose tissue as a source of mesenchymal stem cells that have the potential to regenerate and repair different body tissues.
U.S. Stem Cell, Inc. is an emerging leader in the regenerative medicine / cellular therapy industry specializing in physician/veterinary training and certification and stem cell products and protocols. USRM also provides stem cell banking for patients and creation and management of stem cell clinics. To management’s knowledge, USRM has completed more clinical treatments than any other stem cell company in the world in the past 20 years, and has certified more than 700 physicians and veterinarians in autologous stem cell therapy worldwide.
1 American Association of Neurological Surgeons & the Congress of Neurological Surgeons.
About U.S. Stem Cell, Inc.
Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue”, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.
http://us-stemcell.com/degenerative-disc-patients-significantly-improve-with-usrms-adipocell-tm-chief-scientific-officer-to-present-data-at-ifats/
1.5 million share traded at 1:30. Build that Base
SUNRISE, FL / ACCESSWIRE / November 21, 2017 / U.S. Stem Cell, Inc. (USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today responded to the recently announced Food and Drug Administration's comprehensive policy framework for the development and oversight of regenerative medicine products, including stem cell treatments.
The framework is described in a suite of four guidance documents that build upon the FDA's existing, risk-based regulatory approach, in order to more clearly describe what products are regulated as drugs, devices, and/or biological products. Two of the documents were issued as drafts, and the other two were issued as final.
This new framework also includes more regulatory guidance for off-the-shelf products that, due to their construct, require more complex, lengthy and expensive entries to market. This is partially because they can involve using third-party stem cells that have been modified, including genetically, which can require more intense scrutiny by the FDA. USRM believes that it's in-clinic stem cell procedures should not be subject to the same regulatory process as off-the-shelf drug products.
Likewise, due to the high ramp-up costs with an off-the-shelf gene or cell therapy product, patients can be up against prices of $475,000 per treatment. USRMs proprietary in-clinic protocols using the patients own tissues/cells are not off-the-shelf gene or cell therapies and can be safely performed in-clinic instead of a hospital, by physicians that are USRM-trained and certified in autologous stem cell therapy practices - procedures that have been and continue to be well documented in the scientific literature with very few complications reported. The costs to patients typically range from $5,000-$12,000.
"As U.S. Stem Cell continues to offer products, education and in-clinic therapeutic services, we are continuing our ongoing communication with the FDA in order to determine more specifically how we best fit into the regulatory model for stem cell therapies," said Mike Tomas, President & CEO of U.S. Stem Cell, Inc. "Our goal is to provide patients in need with regenerative medicine using the cells inside their own body, and we are hopeful that the FDA is willing to continue to work with us to help define fair regulation for the public regarding these therapies."
According to the FDA, this modern framework is intended to balance the agency's commitment to safety with mechanisms to drive further advances in regenerative medicine, so that innovators can bring new, effective therapies to patients as quickly and as safely as possible.
"We're at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine," said FDA Commissioner Scott Gottlieb, MD, who is quoted in the guidelines.
"Just as Dr. Gottlieb has described it, the emerging field of stem cell therapy is dynamic and complex," said Dr. Kristin Comella, Chief Science Officer of USRM. "That's one of the reasons why the FDA is taking great consideration, to ensure a comprehensive framework that will simultaneously increase access to these remarkable innovations, while at the same time ensuring public safety. It is also one of the reasons why we here at USRM are so excited to pioneer the holistic approach of using one's own stem cells in clinic - the sophistication of using autologous stem cell therapies, combined with simplicity of application and use, gives clinics we operate and physicians we train incredible scalability with powerful results. As we continue to grow and expand our business, we are confident that our place in this world of emerging science will be reflected in the FDA's ongoing regulatory decisions. We look forward to being a part of this dialogue as this historic scene unfolds."
In addition to the final documents, the two draft guidances also provide important information to help spur development and access to innovative regenerative therapies. The first draft guidance, which builds off the regenerative medicine provisions in the 21st Century Cures Act, addresses how the FDA intends to simplify and streamline its application of the regulatory requirements for devices used in the recovery, isolation, and delivery of regenerative medicine advanced therapies (RMATs), including combination products.
The second draft guidance describes the expedited programs that may be available to sponsors of regenerative medicine therapies, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review, and Accelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation - including tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, as well as gene therapies that lead to a durable modification of cells or tissues (including genetically modified cells). USRM intends to take full advantage of this RMAT opportunity and join strategic partners to apply for consideration of its MyoCell product for heart failure patients.
Based on these draft guidance documents, the FDA will continue to require a robust clinical trial program for these products which typically costs hundreds of millions of dollars and years of studies. USRM has spent more than $100 million over two decades on both preclinical (animal) and clinical (human) trials using its MyoCell™ product. The trials published to date show culture-expanded autologous stem cells directly injected into the heart can provide benefit to congestive heart failure patients. USRM is actively seeking strategic partners to pursue commercialization of the MyoCell product and finalize RMAT designation based on the draft guidelines published.
At U.S. Stem Cell and our clinical affiliates, we have demonstrated a strong safety profile with our in-clinic physician medical procedures which is completely in line with the risk-based approach that the FDA intends to enforce. We believe that patients have a right to utilize the cells in their own body to help promote natural healing and we have demonstrated the safety of these therapies in our recent publication in a peer-reviewed journal. The study describes the use of stromal vascular fraction (SVF) in the clinic for degenerative diseases in orthopedics, neurological and systemic conditions in 676 patients.
U.S. Stem Cell, Inc., is an emerging leader in the regenerative medicine/cellular therapy industry and has, to management's knowledge, completed more clinical treatments than any other stem cell company in the world in the past 20 years. We look forward to pioneering this space and working closely with regulatory bodies to ensure safety.
About U.S. Stem Cell, Inc.
U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development, and commercialization of cell-based therapies that prevent or treat disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases, ultimately, we contend, lessening patient burdens, as well as reducing the associated economic impact disease imposes upon modern society.
Our business, which includes three operating divisions (U.S. Stem Cell Training, Vetbiologics and U.S. Stem Cell Clinic) includes the development of proprietary cell therapy products, as well as revenue generating physician and patient-based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.
Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may", "will", "to", "plan", "expect", "believe", "anticipate", "intend", "could", "would", "estimate", or "continue", or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.
Media Contact:
U.S. Stem Cell, Inc.
13794 NW 4th Street, Suite 212
Sunrise, Fl 33325
Phone: 954.835.1500
Email: usstemcell@us-stemcell.com
SOURCE: U.S. Stem Cell, Inc.
Should the FDA relax rules on Compassionate Access to New Drugs? What if your child was in need of Stem cell therapy. Would you have a different perception?
Bill H.R. 878: Right to Try Act of 2017 https://www.govtrack.us/congress/bills/115/hr878
#NOTGETTINGMYSHARES
USRM forming a base here. Stock taking a breather after running up in price for several days. One of the characteristics of a basing of a stock is decline in volume activity. We are there..!!
House to vote on ‘Right to Try’ bill for terminally ill patients
Posted on Tuesday, March 13, 2018 by CNN in Election
The House is set to vote Tuesday on a bill that would give terminally ill patients the right to seek drugs that remain in a clinical trial phase and not yet fully approved by the Food and Drug Administration.
The bill, however, doesn’t mandate that companies must provide the drugs to those who ask for them.
The Senate passed a similar bill by unanimous consent last year, and the House made changes to it, meaning it will need to go back to the Senate for another vote if the House passes it Tuesday. Patients would be allowed to access drugs that have completed a Phase 1 clinical trial.
Proponents of the bill argue that it gives patients another chance to pursue treatment after exhausting other options or if they don’t qualify for clinical trials due to inclusion criteria. So-called “Right to Try” laws already exist in 38 states, and backers argue a federal law is needed to ensure greater continuity across state lines.
President Donald Trump brought renewed attention to the effort in January when he mentioned the proposal in his State of the Union address, saying “patients with terminal conditions should have access to experimental treatments that could potentially save their lives.”
After it was passed by the Senate, the House Energy and Commerce Committee worked to add changes to address concerns about the bill. The House version, which was released over the weekend, seeks to narrow the scope of eligibility to patients in which there is “reasonable likelihood that death will occur within a matter of months” or “a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death.”
The Senate version included a broader definition of eligibility that could have included chronically ill patients.
The House version also requires that patients get the same informed consent details about the drug as a patient who’s already undergoing clinical trials. And it includes real-time adverse event reporting and a standard to notify the FDA when a company provides an unapproved drug to a “Right to Try” patient.
The bill has long-time support from Vice President Mike Pence as well as conservative groups like Freedom Partners and Americans for Prosperity, two groups backed by the conservative donors David and Charles Koch.
The FDA already has a program in place, the Expanded Access Program, that grants terminally ill patients access to investigational drugs. Scott Gottlieb, commissioner of the FDA, said at a congressional hearing in October that the FDA authorized 99% of the more than one thousand requests “in recent years.”
“Emergency requests for individual patients are usually granted immediately over the phone and non-emergency requests are generally processed within a few days,” he said.
But “Right to Try” advocates argue that patients can save even more time by bypassing FDA permission and certain regulations.
While the bill cleared the Senate easily, it faces stronger opposition in the House. The top Democrat on the Energy and Commerce Committee, Rep. Frank Pallone, issued a statement Monday blasting the bill as needless legislation that undermines the FDA’s approval process and gives patients “false hope,” since it doesn’t require manufactures to actually provide the drugs to the patient.
Critics also fear the legislation could carry broader implications and lead to a slippery slope of bypassing FDA regulations for less urgent cases, such as those with chronic illnesses, for example.
“It’s all well and good and it seems like a nice thing to do for patients, but it’s actually probably not going to open up much access to them than what the FDA already approves,” said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania. “The bigger challenge is this attack on the FDA’s very reason for existence.”
Marilyn Mongiello, a “Right to Try” advocate along with her husband, Frank, who was diagnosed with ALS and whose name is in the title of the House bill, said those who want to try experimental drugs know they’re not getting guaranteed access to the medicine. She acknowledged the bill won’t require companies to provide the drugs, but she said it removes one more hurdle for the opportunity to access them.
“There is no such thing as false hope. Because while there is breath, there is hope,” Frank Mongiello, who is unable to use his voice, said in an email using eye tracking technology.
It’s unclear yet just how much Democratic resistance the bill will face Tuesday. A House Democratic leadership aide said “there are serious concerns among Democrats about how the bill threatens patient safety, undercuts the drug development process, and provides no legal recourse for patients harmed by unapproved drugs.”
For those who oppose the bill, however, it could be a politically tough vote in an election year.
“Are Democrats really going to deny critically ill patients every opportunity to find treatment? This is state law in 38 states,” said a senior Congressional Republican aide. “Are they going to go against their own constituents?”
https://gantdaily.com/2018/03/13/house-to-vote-on-right-to-try-bill-for-terminally-ill-patients/
The 'Right to Try' scam: The Koch brothers' attempt to emasculate the FDA is about to get a House vote
Michael Hiltzik
Mar 12, 2018 | 2:40 PM
The 'Right to Try' scam: The Koch brothers' attempt to emasculate the FDA is about to get a House vote
Vice President Mike Pence wants to undermine the FDA's authority to judge the safety and efficacy of the drugs you're given, in the name of "freedom" — and to please the Koch brothers. (Joshua Gunter / Associated Press)
Few Washington practices are creepier than the exploitation of the desperately ill for ideological ends. That hasn't stopped the sponsors of the egregious federal 'right to try' bill from scheduling the measure for a crucial House vote Tuesday.
The version to be voted on was formally introduced only Monday. (Pro tip: If a bill is sneaked onto the legislative calendar in the dead of night, it's probably not a good bill.) The sponsors imply that this is an improved version over the measure we wrote about in January. But experts who have examined the language, including Holly Fernandez Lynch of the University of Pennsylvania, regard the changes as modest and largely window dressing.
What hasn't changed is the goal of the bill's promoters, a right-wing gang that includes the Koch Brothers and the Arizona-based Goldwater Institute, to use the bill to undermine the Food and Drug Administration. Their campaign is part of their program to undercut government regulations in the name of "liberty" and "choice" — the choice to get injured and killed by doctors and drug companies chasing profits, presumably.
Are we prepared to abandon the FDA’s gatekeeping role in favor of unfettered patient autonomy and market forces?
If the bill passes, it would probably have to go back to the Senate to iron out differences with an earlier version that chamber passed, and then to President Trump's desk. Since Vice President Mike Pence is a big supporter, it's likely the bill would be signed.
That would create a public health hazard. The right-to-try bill would cut the FDA out of the approval process for drugs administered to terminal patients. Except in certain cases, it also would bar the FDA from using any adverse outcomes related to those treatments as evidence in future approval processes for the drugs. In other words, if a drug sickened or even killed a patient, that couldn't be used in its review of whether the drug is suitable for the general public.
Fernandez Lynch and Steven Joffe, her colleague at Penn, warned in a recent article in the New England Journal of Medicine that granting patients with life-threatening illnesses a "right to try" experimental drugs without FDA oversight is a steep, slippery slope. "This logic could ultimately extend to patients with serious chronic illnesses and… to all patients who find their approved treatment options unsatisfactory."
Right-to-try laws are hazardous to your health--and now they're backed by the Koch brothers
Column
Right-to-try laws are hazardous to your health--and now they're backed by the Koch brothers
Jan 22, 2018 | 2:35 PM
The consequences could reach all patients who depend on the FDA to determine the safety and efficacy of drugs. "Are we prepared to abandon the FDA's gatekeeping role in favor of unfettered patient autonomy and market forces," Fernandez Lynch and Joffe asked, "risking precisely the problems that prompted Congress to grant the FDA its present authority?"
The Koch network doesn't want you to know about its ulterior motives. That's why two of its representatives, Nathan Nascimento and David Barnes, responded to my earlier column about the bill by utterly misrepresenting the piece and neatly avoiding mentioning the goal of cutting the FDA out of the drug approval loop.
Let's take another look at what this bill would do, along with its supposed improvements.
The measure would allow patients with irreversible terminal illnesses to try any drug that has passed its phase 1 clinical trials under FDA rules. Phase 1, however, is a very coarse screen for safety and efficacy, designed to determine whether a drug is safe enough to undergo further testing, not whether it's safe generally.
The measure, as currently written, would cover patients who are mortally ill, have "exhausted approved treatment options" or who can't participate in an FDA-approved clinical trial, in part because participation is "not feasible."
Quackbuster David Gorski notes that the feasible language is "pretty vague." He asks, "Could it mean that the patient is unwilling to be randomized or just doesn't like the requirements of a clinical trial?" Gorski observes that another supposed safeguard for patients — that their treatment be covered by informed consent and approved by an institutional review board or IRB — is fairly toothless without FDA oversight, since there are "pretty lax IRBs for hire."
The new version keeps in place an absolution against liability lawsuits for "manufacturers, sponsors, physicians, clinical investigators, and hospitals that participate in the existing expanded access program," but adds that the protection doesn't apply if there is "reckless or willful misconduct, gross negligence, or an intentional tort." In other words, in many if not most cases, a patient who's injured by the last-ditch treatment can't sue the people who gave it to them.
Then there's the restriction on the FDA's using adverse outcomes in right-to-try cases when it judges the drug down the road. The new version has a carve-out of this provision if the Secretary of Health and Human Services determines that the information "is critical to determining the safety of the eligible investigational drug."
That is an improvement, but it's still on a case-by-case basis. Gorski isn't fooled. He notes that the determination process will be burdensome enough "to discourage the FDA from using clinical outcomes in its drug approval decision-making process."
Gorski calls the "right-to-try" campaign "a cruel sham," and he's right. It's all about emasculating the FDA, which exists to protect all patients from harm, and not at all about compassion for the terminally ill. "It's far more about dismantling the FDA and giving drug and device manufacturers more freedom to market drugs and devices with much less testing," he writes.
We know this because one thing the right-to-try gang never explains accurately is that the FDA already has a system in place to give terminally ill patients the right to seek experimental treatments.
The bill's promoters claim that this is still an obstacle for the patients, but that's nonsense. The FDA approves virtually all those requests, Fernandez Lynch and Joffe report, but sometimes the agency recommends "safety-oriented" changes in the treatments based on confidential information it has but that isn't available to the patients' doctors. "Cutting the FDA out of the process," they say, would deprive patients of that last measure of protection.
The FDA has made great strides in "balancing the needs of desperate patients and the principle that all patients deserve evidence that the benefits of medical products justify their risks," they write. "We upset that balance, and diminish the FDA's public health mission, at our peril."
Keep up to date with Michael Hiltzik. Follow @hiltzikm on Twitter, see his Facebook page, or email michael.hiltzik@latimes.com.
http://www.latimes.com/business/hiltzik/la-fi-hiltzik-right-to-try-20180312-story.html
House to vote on 'Right to Try' bill for terminally ill patients
By Ashley Killough, CNN
The House is set to vote Tuesday on a bill that would give terminally ill patients the right to seek drugs that remain in a clinical trial phase and not yet fully approved by the Food and Drug Administration.
The bill, however, doesn't mandate that companies must provide the drugs to those who ask for them.
The Senate passed a similar bill by unanimous consent last year, and the House made changes to it, meaning it will need to go back to the Senate for another vote if the House passes it Tuesday. Patients would be allowed to access drugs that have completed a Phase 1 clinical trial.
Proponents of the bill argue that it gives patients another chance to pursue treatment after exhausting other options or if they don't qualify for clinical trials due to inclusion criteria. So-called "Right to Try" laws already exist in 38 states, and backers argue a federal law is needed to ensure greater continuity across state lines.
President Donald Trump brought renewed attention to the effort in January when he mentioned the proposal in his State of the Union address, saying "patients with terminal conditions should have access to experimental treatments that could potentially save their lives."
After it was passed by the Senate, the House Energy and Commerce Committee worked to add changes to address concerns about the bill. The House version, which was released over the weekend, seeks to narrow the scope of eligibility to patients in which there is "reasonable likelihood that death will occur within a matter of months" or "a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death."
The Senate version included a broader definition of eligibility that could have included chronically ill patients.
The House version also requires that patients get the same informed consent details about the drug as a patient who's already undergoing clinical trials. And it includes real-time adverse event reporting and a standard to notify the FDA when a company provides an unapproved drug to a "Right to Try" patient.
The bill has long-time support from Vice President Mike Pence as well as conservative groups like Freedom Partners and Americans for Prosperity, two groups backed by the conservative donors David and Charles Koch.
The FDA already has a program in place, the Expanded Access Program, that grants terminally ill patients access to investigational drugs. Scott Gottlieb, commissioner of the FDA, said at a congressional hearing in October that the FDA authorized 99% of the more than one thousand requests "in recent years."
"Emergency requests for individual patients are usually granted immediately over the phone and non-emergency requests are generally processed within a few days," he said.
But "Right to Try" advocates argue that patients can save even more time by bypassing FDA permission and certain regulations.
While the bill cleared the Senate easily, it faces stronger opposition in the House. The top Democrat on the Energy and Commerce Committee, Rep. Frank Pallone, issued a statement Monday blasting the bill as needless legislation that undermines the FDA's approval process and gives patients "false hope," since it doesn't require manufactures to actually provide the drugs to the patient.
Critics also fear the legislation could carry broader implications and lead to a slippery slope of bypassing FDA regulations for less urgent cases, such as those with chronic illnesses, for example.
"It's all well and good and it seems like a nice thing to do for patients, but it's actually probably not going to open up much access to them than what the FDA already approves," said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania. "The bigger challenge is this attack on the FDA's very reason for existence."
Marilyn Mongiello, a "Right to Try" advocate along with her husband, Frank, who was diagnosed with ALS and whose name is in the title of the House bill, said those who want to try experimental drugs know they're not getting guaranteed access to the medicine. She acknowledged the bill won't require companies to provide the drugs, but she said it removes one more hurdle for the opportunity to access them.
"There is no such thing as false hope. Because while there is breath, there is hope," Frank Mongiello, who is unable to use his voice, said in an email using eye tracking technology.
It's unclear yet just how much Democratic resistance the bill will face Tuesday. A House Democratic leadership aide said "there are serious concerns among Democrats about how the bill threatens patient safety, undercuts the drug development process, and provides no legal recourse for patients harmed by unapproved drugs."
For those who oppose the bill, however, it could be a politically tough vote in an election year.
"Are Democrats really going to deny critically ill patients every opportunity to find treatment? This is state law in 38 states," said a senior Congressional Republican aide. "Are they going to go against their own constituents?"
CNN's Deirdre Walsh contributed to this report.
http://www.msn.com/en-us/news/msn/house-to-vote-on-right-to-try-bill-for-terminally-ill-patients/ar-BBK9DE4
Congress May Finally Give the Terminally Ill the Right to Try New Drug Treatments
The current process for gaining Food and Drug Administration (FDA) approval for new medications is long and expensive. According to Tufts University, it takes an average of 10–15 years for a drug to be developed by a research lab, approved by FDA, and then finally delivered to sick patients. And the cost to do so is perhaps even more staggering: $2.7 billion.
During this lengthy approval process, years are spent in clinical trials. Potential treatments are researched and reviewed, and then the most promising drugs are eventually tested on a small sample of consenting patients, but only with FDA approval. Patients seeking to use investigational drugs during this process can either wait years for FDA approval or go through a lengthy and difficult FDA exemption system.
Making matters even worse, the exemption process is flawed. It requires physicians to submit paperwork that takes almost 100 hours to complete while still blocking access to potentially lifesaving drugs for thousands of suffering patients. Even after this occurs, the decision lies with FDA, not with the patient and their doctor. The current exemption system is not efficient or expedient enough to provide the timely access to experimental drugs that ailing patients need.
Consider the case of Mikaela Knapp. At age 25, Mikaela was diagnosed with a rare form of kidney cancer. To access experimental treatments that could save her life, Mikaela and her husband, Keith, launched a national social media campaign that culminated with an appearance on Good Morning America. Sadly, Mikaela never received treatment and passed in 2014. She might still be here today if she had the right to try.
A bill now being considered in Congress could dramatically streamline this process and open up access to new drugs for victims like Mikaela and thousands of others nationwide. This right to try legislation would allow patients and their doctors to request investigational drugs from manufacturers without first obtaining FDA approval. Instead of stopping access to life-saving medications, the government would stand aside and permit patients the right to try drugs that have that have undergone preliminary testing in humans and Phase One trials. In 2017, the U.S. Senate passed right to try by a wide bipartisan vote, a minor miracle in today’s political climate. Earlier this year President Donald Trump mentioned right to try in his State of the Union speech, giving the proposal even more momentum.
Like most good policy ideas, right to try started out as a state-based policy; it’s been passed in 38 states. The federal proposal would provide legal protection for health care providers and drug manufacturers. Providers would be protected from license revocation or sanction based on the recommendation of investigational treatments. Manufacturers would be protected from culpability as well, and patients would take responsibility for using a drug that has not been fully vetted.
Defenders of the status quo have claimed that the effort to provide drugs to terminally ill patients creates a false hope, but right to try is far better than no hope, especially for those near death. Nobel laureate Milton Friedman observed the FDA drug approval process, lengthened in the name of safety, has done “enormous harm to the health of the American public by greatly increasing the costs of pharmaceutical research, thereby reducing the supply of new and effective drugs.”
State right to try laws have always faced barriers put in place by current federal drug-approval laws and regulations. A national right to try law would set a new baseline for states, allowing for investigational drugs to be requested and used by patients. States would then be allowed to expand upon the law as they see fit.
Right to try may be saving lives already. One example promoted by the Goldwater Institute is the positive results found by Dr. Ebrahim Delpassand in Texas, where he has helped nearly 100 patients using Texas’ right to try law by providing a new treatment for advanced-stage neuroendocrine cancer. Dr. Delpassand was able to help many of these patients enjoy another year or more with their families when they had been told they had only months to live.
Right to try laws allow patients, with the advice of their doctors, to choose what treatments to try when all else has failed. These laws take steps to ensure the drugs are reasonably safe and that drug manufacturers and patients work to manage legal risks. Congress should follow the lead of the states, the urging of President Trump, and pass right to try legislation.
Tim Huelskamp, Ph.D., is president of The Heartland Institute, a nonpartisan, nonprofit research center headquartered in Arlington Heights, Illinois. Matthew Glans (Mglans@heartland.org) is a senior policy analyst at The Heartland Institute.
https://townhall.com/columnists/congressmantimhuelskamp/2018/03/13/congress-may-finally-give-the-terminally-ill-the-right-to-try-new-drug-treatments-n2460231
Ben Greenfield is a cult figure among fitness fanatics, a guru to the sort of nerds who devote themselves to meticulously monitoring their own biometric data for insight into their personal health. He has more than 50,000 Twitter followers, 60,000 Facebook fans, and 30,000 YouTube subscribes. Now he may become known for something else entirely: Injecting himself with stem cells in hopes that it will make his dick bigger.
“I want to take care of my body in the best way possible,” Greenfield said during a webinar earlier this month, in which he spoke to listeners while walking on a treadmill. Part of that, he said, means “having fun with using what science has given us to make the body better.”
Greenfield is something of a human science experiment, who’s willing to try almost anything in the name of getting ripped and some publicity. He has subjected himself to platelet-rich plasma injections, stem cell injections, and even sound wave therapy, all in search of bodily enhancement and better health.
“I live my life as an N=1,” he told Gizmodo, referencing research studies with just one subject.
In November, Greenfield visited U.S. Stem Cell, a controversial clinic in Florida, to have his penis injected with his own stem cells. If the name of the clinic seems familiar, that’s because it’s the same Florida clinic that last year unintentionally blinded three patients in a clinical trial of an unproven stem cell therapy. In August 2017, the Food and Drug Administration sent U.S. Stem Cell and its chief scientific officer Kristin Comella (who appears in the webinar video with Greenfield) a warning letter for “marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.” U.S. Stem Cell Clinic, the FDA said, even tried to interfere the FDA’s investigation by denying agency employees access to facilities. (U.S. Stem Cell did not respond to repeated requests for comment.)
“I wanted to go from good to great, and to get a bigger dick,” he told Gizmodo. “I’m not going to lie, that’s why guys without erectile dysfunction would do this.”
In the webinar, Greenfield and Comella explain how the procedure worked. Greenfield had U.S. Stem Cell isolate stem cells from his body’s fat cells. Then, said Greenfield, those stem cells were injected into the “meat of the tissue” of his penis. (“You don’t feel a thing other than a little bit of pressure,” he said in the webinar.)
Several early-stage studies have shown that stem cells do show promise in treating erectile dysfunction in men. A press release from U.S. Stem Cell cites one such study from 2016, in which adipose-derived stem cells were used to treat 17 men who suffered from erectile dysfunction after undergoing a radical prostatectomy for prostate cancer. The stem cells were injected at the base of their penis. The men experienced limited side effects, and eight of the 17 men were able to successfully get erections and have sex again. Greenfield, though, was seeking to enhance his manhood, rather than to fix any medical problem. The evidence that such a treatment could help treat erectile troubles is still nascent. Evidence that it could enhance a man without any such issues is even more tenuous.
Kiki Sanford, a molecular physiologist and host of The Stem Cell Podcast, told Gizmodo that while the study cited in the press release suggests the injections might not be harmful, it was also too small of a study to really indicate whether they might actually work, even in men with erectile issues.
“You can’t say that since a study might have enhanced function in deficient tissue it will do the same in normal tissue,” Sanford said. “The body doesn’t necessarily work that way.”
And, she said, even if the procedure is “safe” there is still risk of complications like infection—all for a procedure that has little chance of working.
Nonetheless, Greenfield said in the webinar that the procedure had made him “noticeably better hung.”
Three or four days after the procedure, he said, it was “almost like it grew.” His erections were also bigger, his penis got harder, and his orgasms were better, he said. The better orgasms, he said, might be a placebo effect, but the anatomical changes in size “cannot be denied.”
“I haven’t taken out a ruler. When inside of my wife, she can tell.”
Gizmodo asked Greenfield whether he had measured his change in size.
“I haven’t taken out a ruler,” he said, explaining that he felt the size fluctuates too much to get a consistent measurement. But he thinks it looks noticeably larger.
“When inside of my wife, she can tell,” he added.
Greenfield, who considers himself a “biohacker,” is a big believer in stem cells. He’s had them in his knee and hip to help him recover from an injury, which he said was successful. He’s also injected them into his own arm as a performance enhancer at home. With the help of stem cells, he said, by the time he is 40 in a few years, he hopes to have attained a biological age of 25.
He told Gizmodo that he thoroughly researches any new therapy he plans to undertake, and he felt confident that this one was safe.
“There is still a risk,” he said. “But the payoff in terms of health is very big. You can’t always wait for things to be thoroughly studied.”
Stem cells do have lots of therapeutic promise. But while most of those treatments are still little more than theoretical, clinics offering stem cell procedures have flourished because FDA regulations allow clinics to inject patients with their own stem cells as long as those cells meet criteria including “minimal manipulation” and are intended to just perform their normal function. Some treatments, including some of those offered by U.S. Stem Cell, seem to flout those rules, but so far the FDA has had difficulty cracking down. That may change, with a new regulatory initiative announced last fall. Several US clinics market better sex through stem cell injections to both men and women, for price tags that run more than $1,000.
“Stem cell therapies are all very exciting for their potential to help people, but very few have been shown to work well enough in clinical trials to gain FDA approval,” said Sanford. “We are still very much in the age of snake-oil with respect to many of the therapies that are being marketed, which is too bad because the potential is there. “
But why would Greenfield, a fitness guru who says he has no problems with getting it up, want to try a risky, unproven procedure on himself?
“It’s not normal,” he said in the webinar. “I don’t think ancient man injected stem cells, especially into his nether region.”
Then he rattled off a laundry list of “modern assailants,” including cellphones, and a list of problems including autism and erectile dysfunction that he believes may be related.
“We’re fighting an uphill battle,” he said.
Injecting his penis with stem cells, he continued, is just one way to combat the perils of modern life.
https://gizmodo.com/this-guy-injected-his-dick-with-stem-cells-to-try-to-ma-1823245542
Trump to Congress: Give terminally ill the 'right to try'
President Trump says terminally ill patients should have access to experimental treatments that could potentially save their lives and should not have to go from country to country to seek a cure.
Several times recently, President Trump endorsed terminally ill patients’ “right to try” drugs not approved by the FDA: “Patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives,” he said in the State of the Union speech.
More than three dozen states and the U.S. Senate have passed laws aimed at providing easier access to experimental treatments that have undergone only the most minimal human testing, and the House will vote on a bill this week. The concept is a worthy one, but the congressional bills need modification before becoming law.
Design a Patient-Centered Approach
With new regulations and new technologies to learn, how can dermatologists stay focused on patients? Plan with the point-of-care in mind.
The “right to try” website, operated by the libertarian Goldwater Institute, promotes allowing “terminally ill Americans to try medicines that have passed Phase 1 of the FDA approval process and remain in clinical trials but are not yet on pharmacy shelves. . . [and] expands access to potentially life-saving treatments years before patients would normally be able to access them.”
But there’s the rub: About three-quarters of drugs that pass Phase 1 will ultimately fail to be approved and never be accessible because they founder on the grounds of safety or lack of efficacy. And of those that do ultimately gain approval, often the use for which the FDA approves them will be very different from the expectations during Phase 1 testing.
The right to try unapproved drugs has the potential to be compassionate and sound public policy, as well as an important statement about individuals’ free will, but as the saying goes, the devil is in the details. The most worrisome detail is that most—perhaps all—of the proposals, including the one introduced last year by Republican U.S. Senator Ron Johnson of Wisconsin, would enable patients to request the drugs after only the most meager safety testing. But safety should be a concern even for terminally ill patients.
Federal regulators are already implementing a version of “right to try.” From 2010-2015, the FDA approved more than 99 percent of applications for “compassionate use” applications, and since then has worked to simplify the process.
Phase 1 testing under the aegis of FDA, often the first time a new drug has been administered to humans, amounts to practically no testing at all. Those trials are performed for a short time on a very small number of subjects, typically 20-80 (paid) healthy volunteers, who often do not provide a good representation of how the drug will affect terminal patients. Those studies are intended to determine what doses of the drug are tolerated (in healthy volunteers) without obvious adverse effects, such as sudden death, seizures, or rapid failure of organ systems. Efficacy testing occurs only in the later stages of drug development.
Some people might say that terminal patients should be allowed to access these drugs because things cannot possibly get worse for people who are dying anyway. Not so. They can get worse. Adverse reactions can make the last days or weeks far more miserable if the drug causes a stroke, liver or kidney failure, neuralgia, or the agonizing Stevens-Johnson syndrome, a reaction to certain drugs marked by an excruciatingly painful rash that spreads and blisters.
Moreover, appropriate dosing schedules, precautions and contraindications are typically discovered only during post-Phase 1 clinical trials, or even after a drug has been on the market. An example of the latter was the discovery last year that the drug Viberzi, which was approved in 2015 to treat inflammatory bowel disease, can cause a serious and painful condition called pancreatitis in patients who do not have a gallbladder. That drug had undergone extensive pre-approval testing on more than 2,600 patients during the pivotal clinical trials.
A Wall Street Journal article on this subject elicited a number of angry responses to the assertion that although individuals’ “right to make choices based on their own judgments about risk and benefit” is important, “[s]ociety also has a role in preventing desperation-driven coercion of patients and their exposure to unacceptable risks.”
One letter-writer to the Journal caviled that, “society most certainly does not have a role in telling terminally ill patients that it knows better about analyzing risks and benefits and denying them choice.” Another commenter offered, “If a patient is terminal and legally competent, why should disapproval by you, or society, or fear of liability (which should be able to be neutralized) rob that patient of a humane, possibly life-extending option?”
They raise legitimate issues but ignore that society frequently intervenes to protect consumers from risks considered unreasonable—for example, by not affording them the freedom to experience the exhilaration of riding a motorcycle without a helmet. And in the pharmaceutical realm, the government polices and interdicts drugs bought via the internet from certain offshore pharmacies known to pose a significant risk because its products are often counterfeit, contaminated or otherwise substandard.
Federal regulators are already implementing a version of “right to try.” From 2010-2015, the FDA approved more than 99 percent of applications for “compassionate use” applications, and since then has worked to simplify the process.
Right to try is a compassionate and worthy concept, but it needs thought and refinement based on an understanding of the drug approval process and of physicians’ commitment to primum non nocere--first, do no harm.
Thus, to invoke the right to try there should be some actual evidence of efficacy, beyond just speculation derived from computer simulations, cell culture or animal experiments. I suggest as an appropriate minimum threshold at least one Phase 2 trial (in which the drug has been administered to patients with the disease or symptom it is ultimately intended for) whose results provide a reasonable expectation of effectiveness. And, of course, the manufacturer of the medicine (most often a drug company, but sometimes a university research laboratory) should have to provide a statement that conveys the uncertainty about the likelihood of a positive response and of the known and possible side effects.
We need to prevent well-intended treatments from being worse than the disease. As one of my medical school professors admonished us, there is a difference between patients actually living longer and interventions that make them so miserable that it just seems like longer.
http://www.foxnews.com/opinion/2018/03/13/right-to-try-unapproved-drugs-advances-personal-freedom-but-risks-must-be-taken-into-account.html
Thank you
PotNetwork Holdings Inc (OTCMKTS:POTN) Shares Face a Critical Test
By Jermaine Farmer - March 12, 2018
PotNetwork Holdings Inc (OTCMKTS:POTN) has put in some work in terms of a consolidative or corrective period. POTN put in a pivot bottom near the $0.30/share level in very early March and has bounced back up to test the 50-day simple moving average around the $0.42/share area. This is a defining battle for shareholders. The pattern shows some clear range support in play, and shares have thus far handled it in a very constructive manner.
In addition, the company just announced that its wholly-owned subsidiary, Diamond CBD Inc.com, achieved over $500,000 in website-generated orders, surpassing all previous online sales records. “Even though February is the shortest month of the year, we reached online sales higher than ever before. Our online sales today not only represent the conversion of event and promotional offers into initial sales but a building base of repeat customer orders that reflect high consumer satisfaction of our products and the value that they represent,” stated Richard Goulding, President.
PotNetwork Holdings Inc (OTCMKTS:POTN) has two wholly owned subsidiaries, First Capital Venture, the makers of Diamond CBD OILS and Sunrise Auto Mall Inc.
Diamond CBD is focused on the advanced research and development of “the industry’s finest premium hemp extracts” and making them available to the global marketplace. The Company’s “notable team”, consisting of hemp industry pioneers and natural product experts, chemists, and scientists, is dedicated to producing “the finest and purest Cannabidiol (CBD) oil.”
POTN’s message continues: “Setting the Company ahead of its competitors, First Capital Ventures Inc and Diamond CBD Inc. deliver advanced product quality to market through the team’s creation of diverse and top quality hemp extracts that contain a broad profile of cannabinoids and other natural hemp derived molecules.
The result is a robust selection of Diamond CBD Oils, made from Industrial Hemp, which enhances the formula to be considered among the most powerful natural CBD E-Liquids on the market. Sunrise Auto Mall, Inc., launched in June of 2014, as an operation geared toward enabling people challenged with bad or no credit in securing quality transportation while simultaneously rebuilding the client’s credit.
POTN has developed a highly profitable business model around the continually rising subprime lending industry. Potnetwork Holdings Inc. acting as the holding company for the present subsidiary is planning to continue to expand from within as well as through future acquisitions.”
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As noted above, the stock has been showing signs of putting in a key pivot at support along recent multi-month range lows around the $0.30/share level. That support has been fueled in part by the company’s announcement that its wholly owned subsidiary, Diamond CBD Inc.com, achieved over $500,000 in website-generated orders, surpassing all previous online sales records.
According to the company’s most recent release, “when comparing results to that of last year, recent sales results show growth in the range of over 300%. Over the course of the last year, the Company’s subsidiary, Diamond CBD, has brought to market over 15CBD brands that have demonstrated high consumer brand recognition and acceptance. These brands are marketed at thousands of retail stores around the country and include CBD oils, edible gummies, vape pens, vape additives pet products, and more. In addition, Diamond CBD has most recently unveiled a new product line, targeting a different sector of the market with Meds BioTech, which provides a specialty line to meet the demand of consumers seeking nutritional supplements.”
We’ve witnessed as much as 29% in gains piled on for shareholders of the name during the five sessions leading into the end of the week of March 9. Moreover, the company has benefitted from a jump in recent trading volume to the tune of 42% beyond its prior sustained average level.
Earning a current market cap value of $113.3M, POTN apparently has about $576k in cash on the books as of its latest reporting documentation, which compares quite favorably with about $30k in total current liabilities. The company has also pulled in about $4.4M in sales for the quarter ended September 30, 2017. This may be a very interesting story and we will look forward to updating it again soon. Sign-up for continuing coverage on shares of $POTN stock, as well as other hot stock picks, get our free newsletter today and get our next breakout pick!
Disclosure: we hold no position in $POTN, either long or short, and we have not been compensated for this article
https://oracledispatch.com/2018/03/12/potnetwork-holdings-inc-otcmktspotn-shares-face-critical-test/
Healthy pause today
Breakout coming
US Stem Cell has a market capitalization of $24.09 million and generates $3.08 million in revenue each year. US Stem Cell employs 7 workers across the globe.
https://www.marketbeat.com/stocks/OTCMKTS/USRM/
Penny stocks are not for everyone, despite the fact that they do have a lot of great attributes. They truly can turn a small investment into a large sum of money pretty quickly (but can just as quickly wipe those dollars out).
For many people, the potential for big rewards does not outweigh the risks. Be honest with yourself, and do not feel bad about walking away from the entire concept. In general, this is often the best choice, because MOST situations involving penny stocks result in many investors taking losses.
The good news: the reason most are wasting their investment dollars is they are buying the wrong stocks, at the wrong prices, and usually for the wrong reasons. These investment risks can be easily avoided, mainly by learning a little bit about the reality of trading penny stocks, which this article will show you.
For example, the vast majority of investors buy penny stocks that trade on the Dark Markets, and almost all of them will lose money. On the other hand, by getting involved with high-quality companies on the more serious and regulated exchanges, you pick investment choices from among legitimate and up-and-coming businesses.
These are mainly serious companies, with proven business models. The penny stocks listed on the best markets just so happen to be very new, or still small, and so are trading for pennies... until they eventually trade for dollars!
This Is What The Monthly Charts Are Saying
September 1, 2017 by JC
The monthly charts aren’t saying anything. Charts can’t speak remember? It’s up to us to take the behavior of the market and come up with our own interpretations of what is going on. There is no easy way to do this, just a lot of wrong ways. To help us continue to stay on the right side of the market, we always need to reevaluate the circumstances and come at it from all sorts of different angles. Usually we try and do that by incorporating International Indexes and Intermarket relationships into our process. Time, however, is probably the best tool we have in order to accomplish this. Using multiple timeframes throughout my process is the best way I know how to identify the direction of the primary trend. It’s hard to miss it when you’re consistently using Daily, Weekly and in this case, Monthly charts in your approach.
I have a lot of Monthly charts, as you can imagine. But the truth is that for this particular segment I try and focus on the message of the charts as a group. This exercise also really helps point out certain trends that you may have missed had you only gone back 5-10 years. These monthly candlesticks also tend to tell a story. So there are a lot of benefits in reviewing monthly charts at least once a, well month, because those are the only times they change.
1.2 million shares traded in 45 minutes. Strong support as we build a new base.
Growth Market Report Initiates Coverage on:
USRM DOWNLOAD: http://GrowthMarketReport.com/signup/?co=USRM
ELTP DOWNLOAD: http://GrowthMarketReport.com/signup/?co=ELTP
Bioheart Inc. (USRM) REPORT OVERVIEW
On March 6th, 2018, Bioheart Inc. closed out the trading session at $0.05 (up 0.21%), compared to the previous day close of $0.05. The volume on the day was 1,440,937 (up 36.35%), compared to the company's previous day volume of 1,056,790. For the twelve months ended December 31st, 2016 vs December 31st, 2015, Bioheart reported revenue of $3.08MM vs $2.19MM (up 40.71%) and basic earnings per share -$0.09 vs -$1.80. Bioheart is expected to report earnings on March 21st, 2018, the report will be for the fiscal period ending December 31st, 2017.
Access Growth Market Report's Bioheart Inc. Research Report at:
http://GrowthMarketReport.com/signup/?co=USRM
Elite Pharmaceuticals Inc. (ELTP) REPORT OVERVIEW
On March 6th, 2018, Elite Pharmaceuticals Inc. closed out the trading session at $0.11 (up 2.90%), compared to the previous day close of $0.10. The volume on the day was 544,971 (up 6.31%), compared to the company's previous day volume of 512,608. For the twelve months ended March 31st, 2017 vs March 31st, 2016, Elite Pharmaceuticals reported revenue of $9.64MM vs $12.50MM (down 22.89%) and basic earnings per share $0.03 vs -$0.01. Elite Pharmaceuticals is expected to report earnings on June 13th, 2018, the report will be for the fiscal period ending March 31st, 2018.
Access Growth Market Report's Elite Pharmaceuticals Inc. Research Report at:
http://GrowthMarketReport.com/signup/?co=ELTP
Our Actionable Research on Bioheart Inc. (OTCQB: USRM) and Elite Pharmaceuticals Inc. (OTCQB: ELTP) can be downloaded free of charge at http://GrowthMarketReport.com/.
ABOUT Growth Market Report
It's no secret that Wall Street analysts spend the lion's share of their time focused on large, well-known companies and securities—they make most of their money from investment banking. As a result, small cap companies are relatively underserved when it comes to top-quality research and analysis. Growth Market Report was developed to fill in that gap.
DISCLAIMER
Growth Market Report is neither a registered broker-dealer nor a registered investment advisor. For more information please read our full disclaimer at http://GrowthMarketReport.com/.
PRESS RELEASE PROCEDURES
The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by Growth Market Report. Growth Market Report is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.
NO WARRANTY
Growth Market Report, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. Growth Market Report, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, Growth Market Report, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.
https://finance.yahoo.com/news/research-key-drivers-growth-bioheart-123000728.html?.tsrc=rss
Cool down over. Nervous sellers taking profits. Will close mid .07's
#NOTGETTINGMYSHARES
Growth Market Report Initiates Coverage on:
USRM DOWNLOAD: http://GrowthMarketReport.com/signup/?co=USRM
ELTP DOWNLOAD: http://GrowthMarketReport.com/signup/?co=ELTP
Bioheart Inc. (USRM) REPORT OVERVIEW
On March 6th, 2018, Bioheart Inc. closed out the trading session at $0.05 (up 0.21%), compared to the previous day close of $0.05. The volume on the day was 1,440,937 (up 36.35%), compared to the company's previous day volume of 1,056,790. For the twelve months ended December 31st, 2016 vs December 31st, 2015, Bioheart reported revenue of $3.08MM vs $2.19MM (up 40.71%) and basic earnings per share -$0.09 vs -$1.80. Bioheart is expected to report earnings on March 21st, 2018, the report will be for the fiscal period ending December 31st, 2017.
Access Growth Market Report's Bioheart Inc. Research Report at:
http://GrowthMarketReport.com/signup/?co=USRM
Elite Pharmaceuticals Inc. (ELTP) REPORT OVERVIEW
On March 6th, 2018, Elite Pharmaceuticals Inc. closed out the trading session at $0.11 (up 2.90%), compared to the previous day close of $0.10. The volume on the day was 544,971 (up 6.31%), compared to the company's previous day volume of 512,608. For the twelve months ended March 31st, 2017 vs March 31st, 2016, Elite Pharmaceuticals reported revenue of $9.64MM vs $12.50MM (down 22.89%) and basic earnings per share $0.03 vs -$0.01. Elite Pharmaceuticals is expected to report earnings on June 13th, 2018, the report will be for the fiscal period ending March 31st, 2018.
Access Growth Market Report's Elite Pharmaceuticals Inc. Research Report at:
http://GrowthMarketReport.com/signup/?co=ELTP
Our Actionable Research on Bioheart Inc. (OTCQB: USRM) and Elite Pharmaceuticals Inc. (OTCQB: ELTP) can be downloaded free of charge at http://GrowthMarketReport.com/.
ABOUT Growth Market Report
It's no secret that Wall Street analysts spend the lion's share of their time focused on large, well-known companies and securities—they make most of their money from investment banking. As a result, small cap companies are relatively underserved when it comes to top-quality research and analysis. Growth Market Report was developed to fill in that gap.
DISCLAIMER
Growth Market Report is neither a registered broker-dealer nor a registered investment advisor. For more information please read our full disclaimer at http://GrowthMarketReport.com/.
PRESS RELEASE PROCEDURES
The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by Growth Market Report. Growth Market Report is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.
NO WARRANTY
Growth Market Report, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. Growth Market Report, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, Growth Market Report, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.
https://finance.yahoo.com/news/research-key-drivers-growth-bioheart-123000728.html?.tsrc=rss
Earnings release Wednesday, March, 21st 2018
https://www.marketbeat.com/stocks/OTCMKTS/USRM/
US Stem Cell is scheduled to release their next quarterly earnings announcement on Wednesday, March, 21st 2018.
USRM +143.45% Year-to-Date
Sudden large price movements can create false buy or sell signals in the RSI. I am concerned and will be watching..