US Stem Cell Inc (USRM)

[Dragon Lady]

Article: STEM CELL DUBIOUS USE Clinicaltrials.gov

DUBIOUS STEM CELL THERAPIES.....Published 7/24/2017

JUST FREAKING AMAZING new to me, a new article about the mis-use of the National Institutes of Health (NHS) and their Federal Govt maintained site, "Clinicaltrials.gov"....and SHAZAM....LOOK WHO'S MENTIONED/DISCUSSED AGAIN, by the author and editors....good ole Bioheart/U.S. Stem Cell Inc of Sunrise FL....freaking imagine that, LOL !!!

https://arstechnica.com/science/2017/07/stem-cell-clinics-using-nih-trial-registry-to-tout-pricey-dubious-therapies/?comments=1

QUOTE OF ENTIRE ARTICLE:
"
SCIENCE —

THE CURIOUS CASE OF ClinicalTrials.gov, WHERE DUBIOUS STEM CELL THERAPIES SEEM LEGIT

After an incident, a bioethicist calls for crackdown as doctors threaten legal action.

BETH MOLE - 7/24/2017, 10:25 AM

Earlier this year, doctors reported the case of three women who went blind after having stem cells derived from their own fat injected directly into their eyeballs—a procedure for which they each paid $5,000. Piecing together how those women came to pay for such a treatment, the doctors noted that at least one of the patients was lured by a trial listing on ClinicalTrials.gov—a site run by the US National Institutes of Health to register clinical trials. Though none of the women was ever enrolled in the trial—which never took place and has since been withdrawn—it was enough to make the treatment seem like part of legitimate, regulated clinical research.

But it wasn’t. And, according to a new analysis in the journal Regenerative Medicine, it’s not the only case of dubious and potentially harmful stem cell therapies lurking on the respected NIH site.
At least 18 ostensible trials listed on the site offer similar stem cell treatments that participants must pay to receive—unlike most trials, which compensate rather than charge participants for experimental treatments. These trials, sponsored by seven companies total, claim to be developing therapies for a wide range of conditions, like erectile dysfunction, type II diabetes, vision problems, Parkinson’s disease, premature ovarian failure, and chronic obstructive pulmonary disease (COPD). However, these trials are largely not backed by preliminary research. None of them has Food and Drug Administration approval—even though the agency has published a draft guidance that suggests these treatments are subject to FDA regulation. And some of the studies are only granted ethical approval by review boards with apparent conflicts of interest and histories of reprimands from medical boards and the FDA.

“Some of these studies, I mean, they’re just so outrageous,” article author Leigh Turner, a bioethicist at the University of Minnesota, told Ars. But, to hook patients, a listing on ClinicalTrails.gov is helpful to stem cell clinics, he explains. “A key thing that these businesses need to do is they need to look legitimate, they need to look credible,” he explains. “Listing studies on ClinicalTrials.gov is in some respects really clever from a marketing perspective—and really dangerous.”

They’re taking a federally funded website supporting clinical research, he said, and using it as a “marketing platform.”

Getting on the list

In his article Wednesday, Turner argued that the NIH should tighten restrictions on registering studies on the site. Right now, registration is largely based on the honor system. It’s up to study sponsors to accurately note whether their study is subject to FDA regulation.

“Some of these studies, I mean, they’re just so outrageous”
Many of the stem cell clinics argue that their work is not regulated by the FDA because they treat each patient with the patient's own stem cells, called autologous-derived stem cells. In many cases, tissue is harvested from a patient—often fat tissue collected using liposuction—then the tissue is processed in some way to obtain stem cells, which get injected back into the patient to treat any of several conditions. This was the case for the three blinded patients who received treatment at a clinic called US Stem Cell (previously known as Bioheart, Inc.).

Autologous treatments are exempt from FDA regulation if the cells are “no more than minimally manipulated” before they go back into the patient, the FDA noted to Ars. But a draft guidance that the agency has not yet enforced states that processing and isolating stem cells from tissue, specifically fat tissue, is not exempt. According to the draft guidance, this procedure involves cells that are “more than minimally manipulated,” because it alters the “original relevant characteristics” of the human tissue.

In a comment to Ars, the FDA said that, once the guidance is finalized, it will be able to apply the proper oversight to these stem cell treatments. In the meantime, it said:

“We recognize that there are a number of clinics operating, which do not register with FDA. Consumers are encouraged to contact FDA and the appropriate state authorities in their jurisdictions to report any potentially illegal or harmful activity related to stem cell based products. We also encourage patients and health care providers to report adverse events associated with cellular therapies to FDA.”
For now, stem cell clinics are skirting FDA oversight. Without enforcement, the only barrier to registering on ClinicalTrails.gov is to have an IRB—institutional review board—sign off. These boards provide ethical oversight of a clinical trial and must be registered with the FDA.

Seedy side of stem cells

But not all IRBs are created equal. In the case of the three women blinded by stem cell treatments, the clinic that performed the procedure, US Stem Cell, reported that it received IRB approval from an organization called International Cellular Medicine Society, or ICMS.

ICMS’ stated goal is to work “to protect a physician’s right to practice stem cell and regenerative medicine.” Its website boasts that the organization collaborates with lawmakers to “define adult stem cell therapies as the practice of medicine.” And, as an investigation by BuzzFeed News noted following the report of the blinded women, the ICMS IRB has met with regulatory trouble, and several of the doctors involved with ICMS have ties to stem clinics and have checkered pasts.

In 2012, the FDA admonished the IRB for, among other things, improperly approving a trial that should have been subject to FDA regulation, approving trials without a quorum of IRB members present, and poor record keeping. Dr. Dean Reeves, a member of the ICMS IRB and a doctor based in Kansas, has been investigated by the Kansas State Board of Healing Arts. He was put on probation in 2012 for improperly treating patients, including not using medical imaging to guide injections. In 2016, he faced further allegations and remains under investigation for improperly treating 16 patients. Another ICMS IRB member, Jay Holland, pled guilty to HIPAA violations in 2009.

The chair of the ICMS IRB review board, David Harshfield, is also director of the Arkansas Institute of Regenerative Medicine and conducts workshops to “teach doctors how to use and successfully market stem cell and [platelet-rich plasma] therapies.”

Following the report of the three blinded women, the ICMS released a statement saying that it had not approved the treatment as it was performed by US Stem Cell. It had only approved for the procedure to be performed on one eye, not both, in patients already suffering from severe vision problems.

But the ICMS IRB continues to oversee clinical trials. Turner tells Ars that it appears to be a key player in the network of stem cell clinics offering dubious pay-to-participate trials of stem cell therapies. In fact, according to documents sent to Ars, it signed off on at least one of the trials that turned up on ClinicalTrials.gov in Turner’s article—a study sponsored by Kimera Society. It involves a $6,500 procedure using autologous fat-tissue-derived stem cells given intravenously to treat COPD. The president of Kimera, Duncan Ross, sent Ars the certificate of IRB approval from ICMS, though it had expired in 2015.

Legal threats and missing patients

The ICMS and its executive director, Reed Davis, did not respond to Ars' request for comment on its approval of these pay-to-participate trials of unproven stem cell therapies. But Ross fiercely defended his trial.

In an extensive e-mail exchange between Turner and Ross—prompted by Ars’ request for comment and on which Ars was CCed—Ross argued that his stem cell treatment did not require FDA regulation. If it did, Ross would need to submit to the FDA an Investigational New Drug (IND) application for the treatment, including preclinical research data showing efficacy and well-crafted protocols. But Ross said he only minimally manipulates the stem cells, thus doesn’t require an IND (which appears to contradict the agency’s draft guidance). In addition, he stated in a phone interview with Ars that an IND application is too large a burden for small clinics, and it can take two or three years to get one “approved.”

The FDA told Ars that it does not actually approve IND applications. Instead, the agency has 30 days to review an IND application and decide if it should be placed on hold or allowed to proceed.

Ross stood by his stem cell treatment, saying it worked unequivocally. However, Ross said that he had only treated “approximately 26 patients” of the 200 he hoped to enroll in the trial. He said he was not able to obtain a sufficient amount of data from those patients. He added that he has since abandoned the trial and is no longer interested in pursuing study of the treatment anymore. “I am interested in stopping the negativity against the greatest advancement in human health in history,” he wrote.

His company also sells a skin treatment and a product called Amnio2, which is described as "100% amniotic fluid" with "twice the growth factors."

Turner continued to pepper Ross with questions, including why he was performing these stem cell treatments with the help of a cosmetic surgeon—a medical specialty not trained in these types of procedures. Ross responded: “they're all cosmetic surgeons, more or less,” referring to other doctors who perform similar stem cell therapies.

As the e-mail exchange went on, Ross's comments became more pointed. At one point he told Turner that he was a “negative conspiracy theorist” and “out of bounds.”

He wrote:

“I encourage you to amend your publication or I am going to bring suit against the institution for defamation or slander. I am going to lobby the journal for the retraction of this publication. I followed the letter of the FDA as it exists at this time and I am not going to have my name disparaged because of your lack of interest in due diligence...You continue to assume I'm being devious in some way and I've had enough.
Buyer beware

Ars reached out to all seven companies that Turner’s analysis turned up as sponsoring pay-to-participate trials of unproven stem cell therapies. Ars e-mailed the companies and/or doctors working with them directly. They include: Ageless Regenerative Institute, the Lung Institute, Cell Surgical Network, Retina Associates of South Florida, MD Stem Cells, and Stem Genex—in addition to Ross’ Kimera.

Besides Ross, Ars only received one response, from Dr. Mark Berman. He is the co-medical director of Cell Surgical Network and 2010 president of the American Academy of Cosmetic Surgery. In a lengthy response to Ars, Berman defended the ethics of charging patients for unproven stem cell therapies.

“When we charge patients a reasonable price for treatment during this investigation, we can subsidize the expense we assume when we treat less fortunate patients,” he wrote. He went on to criticize academic institutions for using tax dollars and endowments to run expensive labs and trials. “Academia continues to get richer at the public expense and complain that charlatans like ourselves are ripping off the public.”

Berman did say that not all stem cell treatments are effective, but that “we’re always honest and straightforward about expectations and limitations.”

According to Turner, that’s not the case. And in particular, he argues, allowing these types of studies on NIH’s ClinicalTrials.gov makes it hard for prospective trial participants and patients to sort the good from the bad. He called on the NIH to better vet entries on the registry.

In a statement e-mailed to Ars, the NIH responded saying:

NIH agrees that it is of paramount importance for potential research participants to know about the potential benefits and risks of participating in clinical research studies. Clinicaltrials.gov has a host of resources aimed at helping participants make decisions about enrolling in a clinical research study, but always recommends that a participant talk with a trusted healthcare professional before starting a trial. We also provide information specifically pertaining to participating in stem cell studies.

We continue to evaluate ways to improve our outreach and engagement with stakeholders, including making our resources more prominently available and easier to digest. We added a prominent disclaimer on the CT.gov homepage in March 2017 stating that “Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study.”

For Turner, that’s not enough. He has followed stem cell clinics for years, watching them proliferate. Last year, he and colleague Paul Knoepfler, a stem cell researcher at University of California, Davis, identified 570 clinics peddling dubious stem cell treatments. As he has worked to shed light on this problem, he says he has gotten other legal threats besides Ross'. He even said that he had trouble publishing his latest article, naming stem cell clinics by name, because journal editors were wary of threats from litigious companies.

The problem isn’t going away, Turner said; it’s getting worse.

Regenerative Medicine, 2017. DOI: 10.2217/rme-2017-0015 (About DOIs)."

END QUOTE ARTICLE IN ITS ENTIRETY.....HOLY FREAKING COW...what a stunning piece of medical investigative journalism..

ANOTHER super scathing SMOKER PIECE...and we knew from court filings that the three blind ladies (or at least one or more) were "intentionally misled" at the USCC clinic via pointing um to "Clinicaltrials.gov" to make them "falsely believe" that Comella had them being "treated" as supposedly part of some legit "clinical trial"- all proven now by the New England Journal Of Medicine and the court documents...to have been a big ole RUSE...wowza..It's hot in the ole USCC/Comella/USRM kitchen if you ask me..and the FDA has the burner turned up on HIGH now...gonna smoke um out with some heat probably....looks like to me...yepper....