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Good bye bushie.
Local MS Patient Traveling to China for Treatment
May 16, 2007 06:55 PM EDT
Riley works for a landscape company.
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(Fort Wayne - WANE) Mikey Riley, 20, is living with multiple sclerosis (MS) and is now packing for a trip to China where he'll have a stem cell transplant to treat his disease.
Riley's first symptom of MS was when he was only 15 years old. His left eye went blind for a month. Then symptoms came back when he was at summer camp. Riley's body went numb on his left side. In July 2005, a spinal tap confirmed that he had MS. He was 18 years old.
"We went through a denial period for a long time," Riley said. "I still say sometimes maybe I just had too much caffeine."
Riley's referring to the tremors he gets now in his legs and arms. Multiple sclerosis is an autoimmune disease that affects the central nervous system. Mikey's body is attacking the myelin, protective tissue around nerves, leaving behind scars called sclerosis. This damages nerves and causes people with MS to lose different abilities.
"The progression of it as his age is going to debilitate him much earlier in life," Dianna Riley, Mikey's mother, said.
Riley predicts he'll be in a wheelchair in the next ten years if he doesn't have some treatment now. His MS is fast progressing and isn't responding to traditional MS medications.
He works for a landscaping company and leads an active lifestyle, so the thought of being wheelchair-bound is devastating. Not treating the MS is not an option for Riley.
"I wouldn't say I'm desperate, but I am willing to try new therapies," Riley said.
So, he decided to look into stem cell transplants. Riley found one at Northwestern University in Chicago. The procedure involves using chemotherapy to wipe out the patient's immune system. Adult stem cells are taken out, frozen and then put back in the person's body. Riley compared it to a computer system re-boot.
The procedure costs more than $100,000 and after several appeals, his insurance, Blue Cross/Blue Shield, would not cover his treatment. It called the transplant experimental, and said it doesn't cover experimental options.
"It's frustrating because we had documentation of it working on several people, so why couldn't they try it on me," Riley said.
The Rileys wouldn't be knocked down and the family started fundraising to pay for the treatment themselves. But then another option came.
"I prayed about it and asked that if there is another treatment I should know about tell me and I'll do my homework," Riley said. "Two days later I got a call from the American liaison from Transplant China."
Riley and his mother leave for China Thursday for a five-week treatment in Shenyang, north of Beijing.
This stem cell transplant uses umbilical cord stem cells. They are given a growth agent, in Riley's case myelin. Riley will have four injections of 15-20 million stem cells and one bone marrow transplant. If everything goes well, Riley's myelin will start to re-grow.
"That's what is being destroyed so if you can re-grow it, that would be perfect. This won't stop the MS, but it could slow it for three to five years," Riley said.
Riley relies on his faith to keep him in good spirits, and said the controversial stem cell procedures should be more widely supported and funded.
"We need to do something," Riley said. "If we can help so many diseases why not put funding into it."
Riley noted his transplant uses umbilical cord so no lives were lost to harvest the stem cells.
The treatment in China is also considerably less expensive. He already paid the $23,000 for the transplant and flights for Riley and his mom were another $3,000. But, he raised $46,000. The rest of the money will be kept in an account with the National Transplant Assistance Fund for him to use for any medical expenses in the next two years. After that, the money will go into another transplant patient's account.
"You never know what live's going to throw your way and I've learned from Mikey you just have to grab a hold of it and do what you have to do," Dianna Riley said. "We'll see what happens next and we'll climb each hurdle when we get to it."
While in China, Riley will update his blog with his progress. Click here to see his blog or make a donation to Riley's fund.
http://www.wane.com/Global/story.asp?S=6526408&nav=0RYb
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Singapore Attracts Four Major Biologics Manufacturing Investments Totaling Close to US$1 Billion in Less Than Two Years
BOSTON, May 8 /Xinhua-PRNewswire/ -- Having established a reputation as
the most competitive and trusted site for pharmaceutical bulk activities
and secondary manufacturing, Singapore is now aggressively pursuing
investments in biologics (Note 1), an area that will drive growth in the
drug industry. We are quickly building critical mass for biologics
manufacturing and expect to maintain this momentum as we attract more
companies.
Note 1: Biologics is the production of protein-based drugs such as
vaccines, hormones and insulin. They are produced by culturing
living cells. (Pharmaceutical medicines are chemically
synthesized.)
In less than two years, Singapore has attracted four major biologics
investments totaling close to US$1 billion. These facilities will be
manufacturing biologics for the global market.
Genentech is building a US$140 million commercial-scale microbial-based
manufacturing facility to produce Lucentis, ranibizumab injection, a
treatment for wet age-related macular degeneration.
Swiss biologics contract manufacturer Lonza is building two commercial-
scale mammalian cell-based contract manufacturing facilities. Lonza's first
US$250 million contract manufacturing facility has been outsourced to
produce Avastin, Genentech's cancer drug. The second US$350 million
facility will support the needs of additional customers.
GlaxoSmithKline (GSK) is constructing a US$200 million E-coli-based
commercial-scale manufacturing facility to produce pediatric vaccines
against meningitis and typhoid.
''These projects are strong endorsement of Singapore as the choice site
for world-class biologics manufacturing. Building critical mass in
biologics will enhance our status as a global hub for biomedical sciences
manufacturing, and raise the bar for competing locations because of the
highly-skilled manpower and complexities associated,'' said Mr. Yeoh Keat
Chuan, Executive Director, Biomedical Sciences Group, Singapore Economic
Development Board (EDB).
BIOLOGICS POTENTIAL GROWTH
Singapore's interest in biologics manufacturing stems from the rising
proportion of biologics drugs approved by the U.S. Food and Drug
Administration (Note 2) and the increasing number of biologics drugs
entering clinical evaluation. The numbers are anticipated to surge in the
coming five years. According to Datamonitor, the compounded growth rate for
biologics is 13% compared to 0.9% for small molecule products.
Note 2: About 30% of all medicines approved by the U.S. FDA in 2006 were
biologics drugs.
CAPABILITIES ACROSS THE ENTIRE BIOLOGICS VALUE CHAIN
Singapore is the only country in Asia developing capabilities across
the entire value chain of biologics in a targeted manner, from research,
pilot- scale production, commercial-scale contract manufacturing,
commercial-scale manufacturing to fill and finish.
To support bioprocess development, the Bioprocessing Technology
Institute has built up research capabilities in mammalian cell culture
technology and expression engineering. Homegrown biologics contract
manufacturer A-Bio Pharma provides clinical-scale biologics manufacturing
services to global pharmaceutical and biotechnology customers. A-Bio Pharma
has secured three contracts from GSK and one from Novo Nordisk. Lonza's two
commercial-scale facilities offer a solution to companies looking to
outsource their biologics manufacturing needs. Genentech and GSK own their
respective commercial-scale biologics manufacturing facilities and
Schering-Plough undertakes fill and finish in Singapore.
BUILDING MANPOWER CAPABILITIES IN BIOLOGICS MANUFACTURING
Singapore has also invested considerable resources over the past five
years in academic and industry courses to create a pool of skilled manpower
in biologics. About 3,500 university graduates and 3,000 technicians are
trained in life sciences every year. Singapore has put in place three key
initiatives for biologics training.
Firstly, in the area of in-curricula training, local universities,
polytechnics and Institutes of Technical Education have established
rigorous academic programs to provide students with a foundation in
biologics manufacturing. These institutes are in close contact with the
industry to ensure their academic programs meet the industry's high
standards.
Secondly, industry-specific training courses equip the workforce with
practical skills and in-depth knowledge of biologics manufacturing.
Companies can leverage these courses to train their employees locally,
before proceeding with company-specific training.
Thirdly, on-the-job training is encouraged by supporting the cost of
sending fresh graduates to biologics manufacturing facilities worldwide,
such as Lonza, for up to 24 months. This EDB-administered initiative aims
to develop a pool of talent with relevant working experience. Currently,
there are about 250 trainees in partners' facilities worldwide.
BIOMEDICAL SCIENCES MANUFACTURING OUTPUT
Output by drug factories in Singapore jumped by over 30% last year to a
record US$14.8 billion, almost four times the production in 2000.
TUAS BIOMEDICAL PARK
Tuas Biomedical Park (TBP) at the westernmost tip of Singapore has been
designed for biologics and pharmaceutical manufacturing. The 370 hectares
of land provides companies with economies of scale by sharing major
infrastructure such as power, water, telecommunication, gas and sewer
requirements. Landscaping has also been integrated to create a conducive
manufacturing environment.
Leading global biomedical sciences companies at TBP include Abbott,
Ciba Vision, Genentech, GSK Biologicals, Lonza, Merck Sharp & Dohme,
Novartis, Pfizer, Wyeth Nutritionals and Wyeth Pharmaceuticals.
To obtain more information, please visit the Singapore Pavilion at
booth number 2533.
For media enquiries, please contact Ruder Finn.
Kim Hamelburg
Senior Associate
Ruder Finn Binder (Boston)
Tel: +1-781-559-0429
HP: +1-202-577-8227
Email: Kim.Hamelburg@rfbinder.com
Rae Chew
Senior Consultant
Ruder Finn Asia (Singapore)
HP: +65-9823-7722
Email: chewr@RuderFinnAsia.com
SOURCE Agency for Science, Technology and Research and EDB
Singapore
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A United Business Media company.
Stem cell injections helping East Troy girl cope with gene disorder
(Published Friday, April 6, 2007 11:07:22 AM CST)
A d v e r t i s e m e n t
By Mike Heine
Gazette staff
HANGZHOU, CHINA-Miracles can happen.
Brooke Barels is proof, her mother says.
Brooke suffers from glucose transporter deficiency (GLUT-1), a spontaneous gene mutation that leaves her with cerebral palsy-like symptoms and delayed brain development.
Speech for Brooke is difficult and limited to strings of up to three words. She can't yet walk on her own, and standing without holding onto something is a challenge.
But it wasn't long after a third injection of stem cells on the 20th floor of a hospital in Hangzhou, China, that something happened.
Brooke Barels, left, shares a laugh with UW-Whitewater student Beth Small at the Barels family home in East Troy recently. Small spends a lot of time with Brooke, who recently returned from China after receiving stem cell injections to help her deal with glucose transporter deficiency (GLUT-1), a spontaneous gene mutation that leaves her with cerebral palsy-like symptoms and delayed brain development.
Al Hoch/Gazette Staff
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Brooke, without provocation, began saying words she's heard thousands of times but had never uttered herself.
Her mom, Vicki, and aunt Cindy Toman, who took 9-year-old Brooke from rural East Troy to China last month, were in disbelief.
"Cindy and I looked at each other and it's like, 'Oh my God! Did you just hear that?'" Vicki said Thursday, a few days after flying back to the United States. "I knew it wasn't in my head. Cindy was there with me.
"Brooke's sounds were more clear, and her words are more crisp."
Brooke received six stem cell injections containing about 60 million stem cells developed from the umbilical cord blood of Chinese babies. It's a procedure unavailable in the United States.
The Barels family hopes Brooke will see improvement with her motor skills, cognitive processes and physical abilities.
Doctors said most of the improvements would come in two to six months.
Working on puzzles is a favorite pastime for 9-year-old Brooke Barels of East Troy.
Al Hoch/Gazette Staff
Order a reprint of this photo
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But Brooke decided not to wait.
Another small miracle happened Thursday at the Barels home.
Brooke looked out her bedroom window and said "ball" and "dog," pronouncing the end sounds of both words. Previously, she would have only said "ba" and "da."
"That was so big," said an excited Beth Small, Brooke's twice-a-week in-home healthcare aid. "She never would have said that before. She's more alert. She pointed to the ball and said, 'ball.'
"You just see it in here eyes that there's more going on in there. It's so exciting."
Vicki and Cindy witnessed Brooke's first breakthrough. Brooke, a big fan of ice cream, "All of a sudden started saying, 'Good ice, Mom,' Spontaneously," Vicki said.
"We didn't have to try to get her to say, 'good ice.' Or have to model or cue her or have to repeat it over and over. She was just out with it. 'Good ice, mom.' That's a big improvement for her."
Vicki knows the improvements will come slowly, but that's all they want-an improved life for Brooke.
The family believes the stem cell injections are safe and that Brooke will never regress. The injections have shown improvements in hundreds of cerebral palsy patients, and few have shown ill effects, Vicki said.
"I'm trying to be realistic about it," Vicki said. "I'd love for independent walking, but I'm hoping for improvement in areas where she's more lacking. But we'd welcome any positive change."
Brooke is active and can walk with a walker and climb stairs with help. She even stood and touched her toes three times in a row, also a new miracle.
It's cognitive development where the Barels are hoping for the most improvement.
Hopefully, "it makes it possible to learn at a quicker pace," Vicki said. "She has the ability to learn, but it's such a slow progression of development. It'd be great for her to be able to speed up that process, the thinking process, the memory."
The stem cells will not cure the genetic mutation. But it appears already that the stem cells have helped.
Vicki hopes other families and American doctors will see the progress her daughter has made and will push for approving more stem cell therapies in the United States.
"Now that we've been to China and I see the possibilities and I've seen the patients that are feeling better and doing better and heard the stories about patients who have come and gone from china and are just improving every day, I'm in more of a position now to say I would be more of an advocate," Vicki said.
"If Brook is living proof that this could help kids and disorders, I would want to do nothing but spread the word of awareness and play a role in making it possible for more kids."
http://www.gazetteextra.com/barels040607.asp
U.S. Hospital Errors Continue to Rise 36 minutes ago
MONDAY, April 2 (HealthDay News) -- Patient safety incidents in U.S. hospitals increased by three percent overall from 2003 to 2005, and the error gap between the nation's best- and worst-performing hospitals remained wide, a report released Monday found.
ADVERTISEMENT
America's top rated centers had 40 percent lower rates of medical errors than the poorest-performing hospitals, the study showed.
The fourth annual HealthGrades Patient Safety in American Hospitals Study, put out by HealthGrades, an independent health care ratings company, examined over 40 million Medicare hospitalization records at almost 5,000 hospitals from 2003 to 2005.
The study found that:
There were 1.16 million patient safety incidents among Medicare patients during the three years of the study. That works out to an incidence rate of 2.86 percent.
During those three years, there were 247,662 potentially preventable deaths in U.S. hospitals. Medicare patients involved in one or more safety incidents had a 25 percent chance of dying.
The excess cost to Medicare associated with patient safety incidents was $8.6 billion from 2003 to 2005.
Ten of 16 types of patient-safety incidents increased over the three years of the study, by an average of almost 12 percent. The greatest increases were in post-operative sepsis (about 34.3 percent); post-operative respiratory failure (18.7 percent); and selected infections due to medical care (about 12.2 percent).
Incidents with the highest occurrence rates were decubitus ulcer; failure to rescue; and post-operative respiratory failure.
If all hospitals had performed at the same level as the top-rated hospitals, about 206,286 patient safety incidents and 34,393 Medicare patient deaths could have been avoided, resulting in $1.74 billion in savings.
"The cost of medical errors at American hospitals in both mortality and dollar terms continues to be significant, and the 'chasm in quality' between the nation's top and bottom hospitals, which HealthGrades has documented in this and other studies, remains," the study's primary author, Dr. Samantha Collier, HealthGrades' chief medical officer, said in a prepared statement.
"But the nation's best-performing hospitals are providing benchmarks for the hospital industry, exercising a vigilance that resulted in far fewer in-hospital incidents among the Medicare patients studied," Collier said.
More information
The American Academy of Family Physicians offers advice on what patients can do to help prevent medical errors.
http://news.yahoo.com/s/hsn/20070402/hl_hsn/ushospitalerrorscontinuetorise
Gene Therapy Tourists
By Hilsum, Lindsey
China
Desperation drove Richard Weissenborn to China. Last July, doctors back home in Houston gave him two months to live. The cancer on his tongue had spread to his lymph nodes - the only option, they said, was drastic surgery to remove part of his neck and face.
Weissenborn, a retired German-born businessman, went on the internet. There, he stumbled across something that surprised him. While US hospitals are reputed to be the most advanced in the world, only in China can patients receive gene therapy, widely believed to be the most promising innovation in cancer treatment. He rang Dr Li Dinggang at Haidian Hospital in Beijing, who told him there was no time to lose - so he got on a plane. Six months later, his life has been transformed.
"I was dying and I had no hope," he said, the day before he was due to return to the United States. "You look at me now, but you have no idea how I looked then. I was spitting blood, everything was swollen. But last Friday I got the results from the PET scan and I'm totally cancer-free."
Dr Li, who was trained at the Johns Hopkins University in the US, describes Gendicine, the gene therapy with which he treated Weissenborn and several hundred other patients, as "a milestone on the order of penicillin". But he does not tout it as a miracle cure.
"Richard is a lucky man and he made the right decision to come to our hospital," he said. "But only after five years, if we see Richard has survived, can we say this is really good. Right now we go case by case."
Gendicine is manufactured in Shenzhen, in southern China, by SiBiono, a Chinese company. It works by reactivating the p53 gene, which acts as a tumour suppressor. The drug is injected directly into the tumour, using a virus as a medium to carry the p53 gene into the cancerous cells. Once the p53 has been reactivated, it causes the cancerous cells to commit suicide and the tumour to shrink. Research shows the treatment to be most effective when it is used in conjunction with either chemotherapy or radiotherapy.
Dr Peng Zhaohui - who returned from the University of California in San Diego to found SiBonio - dismisses criticism of the Chinese authorities for approving the treatment precipitously. "When Gendicine was approved in 2003, we'd only had just over a hundred cases and it wasn't a very long observation period before that. It was licensed based on short-term effectiveness," he admits. "But today we've had more than 4,500 cases and have followed up our patients for six years."
None of this is by accident: the Chinese government backs companies such as SiBiono because the long-term plan is to base the Chinese economy on innovation, not manufacturing. Moreover, they see science as a way of reasserting what they regard as China's rightful place in the world. Hundreds of highly skilled doctors and biochemists like Dr Li and Dr Peng are returning from the US because research possibilities are opening up in China. Trials are much cheaper, and there's little chance of patients suing.
Some US researchers say Dr Peng hasn't been transparent about his research because he has published in Chinese-language and not English-language medical journals. SiBiono continued to develop Gendicine after a patient in an American trial of a similar drug died, possibly in reaction to the virus used as the medium. His family sued, and the US Federal Drug Administration put trials for such therapies on hold for three years. A similar problem occurred in France. China was able to take advantage of the slowdown.
This has caused some resentment. A press release from the British- based company Ark Therapeutics, which is developing a gene therapy for brain tumours, states that-if approved-its drug Cerepro "will be the world's first gene therapy product". It adds as a footnote, "outside China", as if China were not part of the world.
But for foreigners like Weissenborn and 200 others who have received treatment here, China is very much part of the world. He paid about 20,000, a fraction of what cancer treatments cost in the US. Such is the demand from foreigners, the Haidian Hospital is opening a new 50-bed international centre next month, with, translators to help patients communicate.
China is also pressing ahead with stem-cell research, including the use of embryonic stem cells, whereas American research is handicapped by opposition from the Christian right.
Weissenborn has no doubts about Chinese ethics. "In the US they take five or sixyears. They want all the facts and the data, but in those years thousands die because they don't get the drug," he said.
http://www.redorbit.com/news/health/829030/gene_therapy_tourists/index.html?source=r_health
OT.........INGN owns over 8% of SR pharma..SR has RNAi tecnology and may be on the verge of a major breakthrough......
British gene team are on the brink of cancer breakthrough
By FIONA MACRAE
Last updated at 10:23am on 4th January 2007
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Join the debate » British scientists are on the verge of producing a drug that could revolutionise cancer treatment.
It shuts down the rogue genes that cause cancer and is due to be tested on humans for the first time in the next few months.
If successful, the drug will be used to stop the disease spreading to other parts of the body, at the same time improving quality of life and life expectancy.
The technique, known as RNA interference therapy, is still in its early stages of development but one day it could be extended to treat other conditions ranging from asthma to Aids.
The drug works by preventing genes from making disease-causing proteins. Similar in structure to DNA, it should halt the disease in its tracks.
A London-based company, SR Pharma, was awarded a patent for a drug which specifically targets the genes involved in pancreatic cancer - one of the most deadly varieties of all.
Animal tests have shown the treatment both stops the tumour from growing and prevents it from spreading elsewhere in the body.
The first human trials are due to start in the next few months and it could be on the market within three years.
SR chairman Iain Ross said: "We are not attacking the tumour itself but attacking the spread. It is not a cure but it will prolong life and improve quality."
Pancreatic cancer accounts for three per cent of all cancers. It is most common in people in middle and old age.
About two thirds of cases are diagnosed in both men and women aged over 70 years. Often the cancer has a poor prognosis as it doesn't show symptoms until the disease is relatively advanced.
Using the same therapy to target other disease-causing genes could one day lead to new treatments for a host of other cancers and illnesses. "If it is proven to work in humans, interfering RNA will dramatically increase the possibility of producing drugs a lot more quickly," said Mr Ross.
Present naturally in the body, interfering RNA is thought to defend against invading viruses.
However, its importance remained unclear until nine years ago when U.S. scientists showed it had the ability to shut down specific genes.
The discovery of the effects of interfering RNA has proved so important that in October last year the U.S. researchers, Dr Andrew Fire and Dr Craig Mello, were awarded the Nobel Prize for Medicine.
Pharmaceutical and biotechnology companies around the world are now trying to produce drugs which harness the phenomenon.
At the forefront of the research, SR Pharma is the closest to testing a cancer treatment on humans.
Experts say the technique has potential - as long as researchers can administer the drug in a way that ensures it is not broken down by the body before it takes effect.
Hazel Nunn, of Cancer Research UK, said: "From laboratory studies it seems that RNA interference techniques could, in principle, hold the potential to treat a range of diseases.
"But we need to see significant advances in methods of delivering RNA into human cells before this technology could be used to treat diseases like pancreatic cancer."
http://www.dailymail.co.uk/pages/live/articles/health/healthmain.html?in_article_id=426399&in_pa...
SR Pharma Congratulates Andrew Fire and Craig Mello on Receiving the Nobel Prize in Physiology or Medicine in 2006
http://www.drugnewswire.com/10073/
No...........any stem info is relevant to this and other co.'s.
Risk vs. hope: S. Floridians go overseas for stem cells
By Nancy McVicar
South Florida Sun-Sentinel Health Writer
Posted December 18 2006
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David Aldrich, 49, was paralyzed in a boating accident more than four years ago, and had made his wishes known. If he were hospitalized again and in a near-death situation, he did not want to be resuscitated.
He thought there was no hope he would walk again.
But with his family's prodding and financial backing, the former licensed boat captain from Delray Beach traveled to China, where doctors are treating people with spinal cord injuries and other conditions with stem cells obtained from umbilical cord blood. Out-of-pocket costs are high -- $20,000 to $25,000 on average.
While some umbilical cord stem cell treatments are available in the United States with special permission from the U.S. Food and Drug Administration, Aldrich said he opted to go to China because spinal cord treatments are not yet available here. The Miami Project to Cure Paralysis is doing research on embryonic stem cells in animals, but is not ready to try the treatments in humans.
Slowed by political opposition, embryonic stem cell research is limited to a small number of cell lines that qualify for federal research dollars. Private companies have raised more than $440 million to advance their work outside the confines of federal funding, but for the most part are still in the early stages of laboratory work and animal experiments.
Several states have enacted stem cell research programs, but they are in their infancies. In Florida, the Supreme Court has been asked to sort out the language in competing proposals for constitutional amendments: One would prevent spending money on embryonic stem cell research; another that would require the state to appropriate $20 million annually for 10 years to pay for such research. Voters could decide the issue in 2008.
Congress is expected to take up the issue again next year.
Opponents of embryonic stem cell research argue that the work is unethical because they say it requires ending a human life -- that of an embryo.
"We are in favor of all types of adult stem cell research and using umbilical cord blood," said Lynda Bell, spokeswoman for the Florida Right to Life Committee. "We support any research that does not require the destruction of a human embryo, but when you're destroying human life to do experimentation, that is wrong."
As the debate rages, some desperate patients are going to other countries -- China, Mexico, the Dominican Republic, Brazil, Portugal, Sweden and elsewhere -- hoping for miracle cures now.
Kayce Barnes, of Margate, has taken her 7-year-old daughter, Brianna, to the Dominican Republic twice for infusions of cells she hopes will save her child from Batten's disease, a rare, fatal degenerative neurological condition.
"If there's any chance to save my daughter's life," she said, "I'll do it."
Brianna's treatment, offered by a California company called Medra, is performed at a hospital in the La Romana region of the Dominican Republic.
A stem cell trial to treat Batten's disease is planned at Oregon Health and Science University's children's hospital, but only six children will be treated initially and Brianna is not a candidate. If the treatment proves safe, the trial could be expanded to include more children, but it could take several years to win FDA approval for all children with the condition.
"She was denied from that trial because they want kids who are less medically involved, kids with very few symptoms," Barnes said.
Researchers in the United States have successfully treated conditions such as sickle cell disease, some genetic diseases and immune deficiencies using umbilical cord stem cells, but the treatments require permission from the FDA and other regulatory oversight, such as institutional review boards, safeguards that may be lacking in other countries.
Bernard Siegel, executive director of the Genetics Policy Institute, which has offices in Wellington and Washington, D.C., said going offshore for such treatments is risky.
"We pay close attention to these so-called stem cell therapies that are taking place outside the United States, and my own personal view is that we must take a very cautionary approach to this," said Siegel, who has organized several international meetings of stem cell researchers.
Three scientific journals, Science, Nature and The New England Journal of Medicine, have reported on China's stem cell programs, and a British trade group that visited there two years ago reported that China might be at the forefront of international stem cell research.
Aldrich's sister-in-law, Sally Aldrich, a retired nurse who lives in New Hampshire, found the site for Stem Cells China and began making inquiries.
She explored other options before she and her husband, Paul, offered David the China option.
"There are people who are saying it's too early to do this, but David and Paul and I are adventurers. You don't get anywhere without risk," she said. "For people like David and Christopher Reeve, all it takes for them to die is an infection."
Reeve, a prominent actor paralyzed when he was thrown from a horse, died Oct. 10, 2004, of an infection.
W. Dalton Dietrich, scientific director of the Miami Project, said there have been preliminary talks with the FDA about how best to conduct clinical trials using a combination therapy that the Miami researchers have shown can restore 70 percent of the movement in paralyzed limbs of rats.
"We're at that phase of the research where we're really thinking seriously about translating it into people, moving things from the bench to bedside, but it's difficult to tell how long that will take," Dietrich said.
When people consult him about leaving the country for stem cells, he said, he advises against it.
"We tell them this is premature and may be dangerous," he said.
David Aldrich thinks the treatments and the physical therapy he received in China have given him more movement in his fingers and legs. His spinal injury is classified as "incomplete," meaning the cord was not severed. His vision was impaired, and he was on a ventilator for months and in the hospital for a year.
He credits the China treatment and rehabilitation with his ability to sit up on his own, and he said his vision also has improved.
"I have more flexibility in my fingers. That's pretty exciting. I can move both legs, and I've got a lot more control of all my limbs. I believe what I'm experiencing is a result of the strength training, and the rehab work while I was there. You can't just put in stem cells one day and get up and walk the next day," he said.
Aldrich said he hopes the climate for research in this country improves soon.
"People are looking for hope, and it's too bad they have to go outside the U.S. to find it. That's all any of us have to look forward to is hope, to cure our disease or improve our quality of life."
http://www.sun-sentinel.com/features/health/sfl-rxstemp18dec18,0,6725196.story?coll=sfla-news-health
Patient-Specific Stem Cells Likely in Six Months
By Kim Tae-gyu
Staff Reporter
An illustrious South Korean scientist projects his team will be able to extract patient-specific stem cells as soon as research with human embryos is allowed in the country.
The scientist is not Hwang Woo-suk, who falsely claimed to have created patient-specific stem cells last year, but Prof. Park Se-pill at Cheju National University.
``Technologically speaking, we will be capable of deriving stem cell lines from cloned human embryos in about half a year,¡¯¡¯ said Park, who harvested stem cells from human embryos in 2000 for the third time in history.
``We have the goal of launching studies on cloned embryonic stem cells and our new lab will have a team for that purpose,¡¯¡¯ said Park, who will open a stem cell research center in Seoul this week.
Patient-specific stem cells are the Holy Grail for embryologists, who believe they will help heal incurable diseases such as diabetes and Alzheimer¡¯s without causing negative immune responses.
The reason: the patient-specific stem cell batches come from cells of patients themselves. Subsequently, therapy with them is just like transplanting the healthy skin of a burn patient to his or her damaged tissue.
In this regard, patient-specific stem cells are sometimes called tailor-made cells _ the country¡¯s discredited veterinarian Hwang said his team cloned 11 such cell lines last year.
However, Hwang¡¯s work proved to be a hoax and research with cloned human embryos has been practically prohibited because of ethical controversies and strengthened guidelines from the government.
``Our new bio center in Seoul, dubbed the Mirae Biotech Research Institute, will start with adult stem cells and frozen embryos rather than cloned embryos. In fact, cloning human cells is not our immediate target,¡¯¡¯ the 46-year-old Park said.
``But we will prepare to embark on studies on cloned embryos by carrying out experiments with animal cloning,¡¯¡¯ said Park, who cloned a cow in 2001.
Park said animal cloning has many technologies in common with cloning human embryos although extracting stem cells from them is a different technique.
The Mirae Biotech Research Institute will open tomorrow at Seoul-based Konkuk University, and eight researchers and five professors from Cheju National University, including Park, will participate in its work.
http://times.hankooki.com/lpage/tech/200612/kt2006121817120811780.htm
Researchers Create Genetically Matched Embryonic Stem Cells For Transplantation
Researchers at Children's Hospital Boston report a new and efficient strategy, using eggs alone, for creating mouse embryonic stem cells that can be transplanted without the risk of rejection because
Related Website: Childrens Hospital Boston The Full Story:
Researchers at Children's Hospital Boston report a new and efficient strategy, using eggs alone, for creating mouse embryonic stem cells that can be transplanted without the risk of rejection because the cells are compatible with the recipient's immune system. The findings will be published online in the journal Science on December 14.
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Though done in mice, the work establishes the principle of using unfertilized eggs as a source of customized embryonic stem cells that are genetically matched to the egg donor at the genes that control recognition of cells by the immune system, making them potentially useful for transplantation therapies. There are several caveats, including the fact that only females could benefit from this technique, donating their own eggs to generate the stem cells, and concerns that the tissues derived from this special type of embryonic stem cells might not function normally.
"This technique, if proven effective in humans, offers an efficient way of generating customized stem cell lines from women," says George Q. Daley, MD, PhD, senior author on the paper, who is the Associate Director of the Children's Hospital Boston Stem Cell Program and a member of the Executive Committee of the Harvard Stem Cell Institute. "It would eliminate tissue matching and tissue rejection problems, a major obstacle to successful tissue transplantation."
Embryonic stem cells are "master cells" that can generate all tissue types in the body. In 2002, Daley's laboratory collaborated with the laboratory of Rudolf Jaenisch, PhD, of the Whitehead Institute, MIT to demonstrate the first use of another method, somatic cell nuclear transfer, to create customized embryonic stem cells to repair genetic defects in mice. But somatic cell nuclear transfer (sometimes called therapeutic cloning) is a technically demanding and inefficient process that involves transferring the nucleus of a donor cell into an egg from which the nucleus has been removed.
"We will not stop testing nuclear transfer, because it is the only means we know for generating embryonic stem cells that are genetically identical to a patient," says Daley, who heads one of two Harvard Stem Cell Institute-associated labs attempting to create human embryonic stem cells with that technique. "However, generating embryonic stem cells from unfertilized eggs is far more efficient than nuclear transfer, and therefore may allow us to move toward human applications sooner."
In the new study, Daley, first author Kitai Kim, PhD, and colleagues at Harvard Medical School, Brigham and Women's Hospital and Massachusetts General Hospital used unfertilized eggs of mice to create so-called parthenogenetic embryonic stem cells. Parthenogenesis is a method of reproduction, common in plants and in some animals, in which the female can generate offspring without the contribution of a male. It doesn't normally occur in mice, but Daley, Kim and colleagues were able to induce unfertilized mouse eggs to develop through a series of chemical treatments, then generated embryonic stem cells.
Next, they used genetic typing to identify those embryonic stem cells that shared with the egg donor the genes responsible for tissue matching, called the major histocompatibility complex (MHC). When they injected these selected embryonic stem cells into MHC-matched mice, a variety of specialized tissues formed, with no rejection and no need to suppress the recipients' immune system.
Daley's laboratory at Children's Hospital Boston is now trying to replicate its results with human eggs.
As Daley noted, there are several potential limitations to embryonic stem cells generated by parthenogenesis. First, since parthenogenetic embryonic stem cells are made from eggs, the technique is only applicable to females. (Methods exist for deriving embryonic stem cells using sperm from men, but these techniques are as technically challenging and inefficient as somatic cell nuclear transfer, Daley says.)
There are also potential safety concerns. Embryonic stem cells created through parthenogenesis have altered expression of certain genes that are "imprinted." Imprinted genes are marked for expression in a special way based on whether they are passed to offspring by the egg or the sperm. Because parthenogenetic embryonic stem cells are made from eggs only, they carry no paternally imprinted genes, and instead carry two copies of maternally imprinted genes. Altered expression of imprinted genes has been linked with cancer and poor growth in some tissues. In addition, embryonic stem cells created through parthenogenesis may have some regions of their genome that contain duplicated copies of mutant genes that have been linked with malignancies or abnormal tissue growth.
"Right now this technique is useful for basic research, but we are hopeful that parthenogenetic cells might prove useful for therapies," Daley says. "Our cells produce normal tissues in mice, and there is a report in the clinical literature of a human patient whose blood was derived entirely from parthenogenetic cells. However, we'll have to demonstrate the safety and durability of cells derived from parthenogenetic embryonic stem cells before we could imagine any clinical use."
The study was supported by grants from the National Institutes of Health, an NIH Director's Pioneer Award of the NIH Roadmap for Medical Research, a Burroughs Wellcome Fund Clinical Scientist Award in Translational Research, the Cooley's Anemia Foundation, and the Leukemia and Lymphoma Society.
http://www.healthnews-stat.com/?id=279&keys=stem-cells-embryonic-stem-cells-mice
Stem cells transplanted for stroke
TAMPA, Fla., Nov. 29 (UPI) -- Stem Cell Therapy INTL said Wednesday it successfully transplanted its stem cell therapy into a U.S. stroke patient.
The procedure took place at one of the company's facilities in Kiev, Ukraine.
The patient is 50-year-old Rich James, a chiropractor from New York City whose left arm and left leg were paralyzed as a result of a stroke earlier this year, and who had achieved only limited results from traditional stroke treatments, the company said.
"After his stroke, Dr. James was in a wheelchair, but could walk short distances with the aid of an AFO and a quad cane," said Calvin Cao, CEO of SCTI. "He traveled to our affiliate clinic in Kiev and received stem cell transplantation therapy as well as physical and massage therapy. At six weeks post treatment, Dr. James can walk without any aids and at four months post treatment he is now able to take the N.Y. subway on his own to get around."
SCTI's therapy is comparable to organ transplantation, except stem cells rather than an entire organ are transplanted into the body, eliminating the risk of rejection, the company said. James learned of SCTI via strokenetwork.org, the company noted.
http://www.upi.com/HealthBusiness/view.php?StoryID=20061129-104457-8218r
George Harrison, MBE (February 25, 1943 – November 29, 2001)
Sen. Reid: Ethics, stem cells top agenda By NEDRA PICKLER, Associated Press Writer
Tue Nov 28, 4:09 PM ET
WASHINGTON - Ethics reform, a higher minimum wage and more money for stem cell research are the top items on the Senate agenda next year, incoming Senate Majority Leader Harry Reid said Tuesday in an interview with The Associated Press.
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Reid said he will tackle those priorities after cleaning up the "financial mess" that the outgoing Republican leadership has left. He was referring to nine long overdue appropriations bills covering 13 Cabinet departments for the budget year that began Oct. 1.
"They're just leaving town, it appears," Reid said from his office in the Capitol. "We hope that's not the case, but it appears that's what they are going to do. And so we're going to have to find a way to fund the government for the next year."
The must-pass legislation totals more than $460 billion and promises to divert time and energy from other items on the Democratic agenda.
Reid also said he's doing away with the "do-nothing Congress" that Democrats campaigned against this year as they ousted the Republican majority in both chambers of Congress. The Nevada Democrat, who is wrapping up his final days as Senate minority leader, will take control of the Senate agenda when the new Congress takes the oath of office in January.
"We're going to put in some hours here that haven't been put in in a long time," Reid said. That means "being here more days in the week and we start off this year with seven weeks without a break. That hasn't been done in many, many years here."
Reid said he hopes that President Bush is willing to work with the Democratic congressional leadership, but the early signs have not been encouraging. He said the White House has not reached out to him since his meeting with Bush in the Oval Office on Nov. 10. "Sorry to say," Reid said.
Bush used the only veto of his presidency so far to reject a bill passed by Congress last year that would have expanded embryonic stem cell research through government funding.
Supporters of such research say it could lead to treatments and cures for a wide variety of ailments, including Alzheimer's and Parkinson's disease and spinal cord injuries. Bush and abortion foes, however, have opposed embryonic stem cell research because the embryos die in the process of harvesting the stem cells from them.
Reid said he hoped the president "will relent and see the light" that the research gives hope to Americans struggling with illnesses and injuries. He said the Senate is "not even close" to having the two-thirds vote necessary to override Bush's veto, but he hopes some Republicans will join the Democrats after losing the election this month.
The election came on the heels of several ethical scandals involving lawmakers, and Reid said reform is needed. He said "the first thing we do" will be to try to cut the practice of lawmakers anonymously inserting "earmarks" — narrowly tailored spending that often helps a specific company or project in their district — into bills.
Citizens Against Government Waste, a taxpayer watchdog group, said there were 9,963 such projects in the spending bills for the 2006 budget year, costing $29 billion.
The third item at the top of Reid's agenda is increasing the minimum wage from $5.15 to $7.25 an hour. The White House has signaled that Bush may be willing to consider the proposal.
http://news.yahoo.com/s/ap/20061128/ap_on_go_co/reid_interview
Researchers Uncover Colon Cancer Stem Cells
By Jessica Berman
Washington
27 November 2006
Scientists have found that a small number of stem cells appears to be responsible for the growth of colon cancer. Stem cells are master cells that can be coaxed to grow into any tissue in the body. But in the case of some cancers, small numbers of stem cells might be the reason why some tumors grow out of control. VOA's Jessica Berman reports.
Experts say no matter how aggressively they are treated with chemotherapy, some cancers seem to come back. These include breast cancer, leukemia's and brain cancer.
John Dick
John Dick of the University of Toronto says researchers have wanted to find out if a similar mechanism is at work with cancer of the colon, which is a leading cause of cancer death in many parts of the world.
"It's critically important because the reality is that despite the therapies that we have available today, still a great number of people who have colon cancer relapse, which means that our therapies are not completely effective," said John Dick.
In paper published in the journal Nature, Dick and colleagues describe their work with a stem cell marker, or protein, called CD133 in colon cancer. CD133 had previously been implicated in prostate and brain cancers.
Only a very small number of colon cancer cells - one in 250 - is rich in CD133.
Dick's researchers discovered that when they injected human colon cancer cells high in CD133 into mice, the tumors flourished, while cells with small amounts of CD133 hardly budged.
A separate paper published in Nature supports the idea that only a very small number of colon cancer cells is responsible for tumor growth.
Ruggero de Maria of Rome's Instituto Superiore di Sanita says he and colleagues are treating cancer cells with high levels of CD133.
"We have cells growing for almost two years now in culture, and they are able to reproduce the same tumor very similar to the tumor from the patients from which we derived these cells," said Ruggero de Maria.
Both De Maria and the University of Toronto's John Dick were interviewed by the editors of Nature.
Before there's talk of a cure, Dick says, researchers need to find out what makes cancers aggressive. He says hopefully, the latest discoveries will help find the answer.
"Leukemia stem cells really spend a lot of their time lying dormant," he said. "And it explains why those cells could be swimming in a sea of chemotherapy agents and they would survive and then would be responsible for growth back. We need to determine what the growth properties are for these colon cancer initiating cells."
http://www.voanews.com/english/2006-11-27-voa2.cfm
Cancer stem cells start tumours in mice
Stem cells — the master cells that give rise to all the blood and tissue in the body — may also be responsible for tumours, according to two separate studies published recently.
Canadian and Italian researchers both found that specialized colon cancer stem cells appeared to be the sources of colon cancer tumours in mice.
Their findings support the idea that future cancer treatments will have to home in on cancer stem cells. Similar findings have been seen for leukaemia, breast and brain cancers, but the two studies are the first to show cancer stem cells are also responsible for colon tumours.
“Colon cancer is one of the best-understood neoplasm’s (tumours) from a genetic perspective, yet it remains the second most common cause of cancer-related death (in Canada), indicating that some of its cancer cells are not eradicated by current therapies,” John Dick and colleagues wrote in their report. They implanted human colon cancer cells into mice with a deficient immune system — a standard way of studying cancer.
Only certain cells, those with a protein on the surface called CD133, were able to initiate a new tumour. CD133 had previously been implicated in brain and prostate cancers.
It may be possible to design drugs that attack only those cells, and thus treat colon cancer in a way that better affects the tumours without hurting healthy cells, the researchers said. reuters
http://www.dailytimes.com.pk/default.asp?page=2006%5C11%5C27%5Cstory_27-11-2006_pg6_20
Science 24 November 2006:
Vol. 314. no. 5803, pp. 1232 - 1235
News Focus
CHINESE GENE THERAPY:
Splicing Out the West?
Jerry Guo and Hao Xin*
BEIJING--Maria Corina Roman, a Danish surgeon, made international news when she decided to seek treatment for her breast cancer using the world's first commercial gene therapy. Disappointed with standard cancer treatment, Roman flew to China in 2004 to try Gendicine, a Chinese product that contains a virus with a human tumor suppressor gene (p53) spliced into its DNA. Just days after the first injection, Roman reported that she had regained energy and appetite. Gendicine's maker, SiBiono GeneTech Co. in Shenzhen, spread the word. Encouraging reports about this gene therapy appeared in the Financial Times, Business Week, and China Daily.
This fall, however, Roman's tumor has returned, SiBiono acknowledges. The company's chief executive, Peng Zhaohui, says nevertheless that the drug has proved to have "good efficacy," adding that Roman, SiBiono's most famous client, "should continue to treat with Gendicine."
Peng's advice is based on more than optimism; it reflects national policy. China's State Food and Drug Administration (SFDA) approved Gendicine for clinical use in October 2003 and licensed its commercial production in spring of 2004. Last year, SFDA approved a second genetically engineered anticancer product: a modified virus, dubbed H101, designed to infect and kill cells containing mutated versions of the p53 gene. The maker, Sunway Biotech Co. in Shanghai, says it expects to strike a licensing deal by the end of this year with Genzyme Corp. in Cambridge, Massachusetts, to run clinical trials of a Genzyme gene-therapy product in China and possibly test H101 in the United States.
As these projects advance in China, gene therapies in North America and Europe are struggling to complete premarket clinical tests. After a U.S. patient died in a 1999 genetherapy trial and two children in French trials developed leukemia in 2002, the U.S. Food and Drug Administration (FDA) tightened controls on experiments, says James Norris, head of the U.K.-based International Society for Cell & Gene Therapy of Cancer. Western companies say they are making progress but have not yet brought a single gene therapy to market.
Some see this as a sign that China is catching up with, or even surpassing, the West. "I think the future of gene therapy will be in China," says Andre Lieber, a genetherapy researcher at the University of Washington (UW), Seattle. But he warns that recent claims of success should be read with caution. There is a "problem" with interpreting clinical studies done in China, Lieber says. Often the primary data are published only in Chinese--raising a barrier to nonspeakers--and even when they appear in English, critical information may be missing (see sidebar, p. 1233).
Intellectual-property rights may be problematic, too. Some researchers in the West have questioned claims of independent innovations made by Chinese drug companies; this could limit sales outside China. Finally, critics argue that the Chinese regulatory system is not rigorous and that Gendicine, for one, was approved with scant evidence of efficacy. With drugs to treat cancer, "the bar is a lot lower than in the United States to get approval," says Frank McCormick, director of the University of California, San Francisco, Comprehensive Cancer Center.
High hopes
On a plot of land in the outskirts of Shenzhen stands an empty building with opaque windows, a site where owners hope a biotech bonanza will blossom. Starting next year, this newly constructed plant will begin producing 1.5 million vials of Gendicine per year, seven times the capacity of SiBiono's current facility, according to SiBiono's Peng. Science visited Peng in his office in May and spoke with him last month by phone.
A hallway at the company's headquarters is plastered with clippings from Chinese and international media describing how Gendicine has helped cancer patients. Peng said SiBiono aims to spearhead the sale of gene-therapy products in China with Gendicine. It was given its Chinese name--jin you sheng, "born again today"--by China's Vice President Zeng Qinghong when he made a ceremonial visit to the company a month before SFDA cleared the drug for market.
SFDA approved Gendicine as a treatment for head and neck cancer based on small clinical trials showing that more patients had tumors disappear with Gendicine plus radiotherapy (64%) than with radiotherapy alone (19%). Peng has called these "phase II/III" trials, an unusual term that combines safety (phases I and II) with proof of efficacy (phase III).
In 2005, SFDA approved Sunway's H101, also designed for treatment of head and neck cancer, after a 160-patient phase III clinical trial showed that 74% of patients receiving H101 plus chemotherapy experienced a reduction in the size of tumors compared to 40% of patients receiving chemotherapy alone.
Gendicine has now been given to more than 4000 patients to treat not just head and neck tumors but also 50 different cancers, Peng claims. The venture thus far has received about $6 million in grants and government start-up funds as well as $6 million from private investors.
Peng projected in 2004 that 50,000 patients would have received Gendicine treatment by the end of 2006. Demand is far short of that target, but if the drug works--and if patients can afford the high price of treatment, costing $1680 to $3360 per cycle--the market could eventually be huge. "Having 1.3 billion potential patients compared to 300 million in the United States makes a successful drug very lucrative in China," says Norris.
Imitation or innovation?
Doubts persist, however, about China's future as a gene-therapy powerhouse. Some U.S. companies allege that China's commercial products are spinoffs of Western inventions with relatively minor modifications. Introgen Therapeutics in Austin, Texas, for example, claims that SiBiono's Gendicine is similar to its own experimental product, a recombinant adenovirus containing the human p53 gene (rAd-p53).
Wei-Wei Zhang, president and CEO of San Diego-based GenWay Biotech, published the first paper on rAd-p53 while working at the University of Texas M. D. Anderson Cancer Center in Houston in 1994. He holds U.S. patents on the viral construct and related processes. M. D. Anderson negotiated a license with Introgen, which has spent more than $70 million to develop a product based on Zhang's rAd-p53, trademarked Advexin. It has been in clinical trials since 1994. The company's ongoing phase III trial using Advexin to treat head and neck cancer is under review for "accelerated approval" by FDA.
Introgen's 106-patient phase II trial in 2005 showed a 10% "tumor response rate," defined by at least 30% reduction in tumor size, in patients who received Advexin alone. Introgen Vice President Robert Sobol says phase III trials are going well.
Meanwhile, Introgen CEO David Nance claims that Gendicine is a "derivative" of his company's product. In an August 2006 filing with the U.S. Securities and Exchange Commission, Introgen claims that Gendicine infringes on a 1994 patent filed in China but concedes that "enforcement of patents in China is unpredictable, and we do not know if monetary damages could be recovered from SiBiono."
Peng disputes these statements. In a phone interview, he said that Gendicine is "very different" from Introgen's product, and that the only similarity is the use of p53.
Sunway acknowledges that its product, H101, was inspired by U.S. research but says it developed H101 independently--a claim that is not disputed. According to Sunway officials and other observers, H101 is similar to a product called Onyx-015, made by Onyx Pharmaceuticals Inc. in San Francisco. Onyx-015 and H101 both use a modified adenovirus to target probable cancer cells that have a deficient or mutated p53 gene. This so-called oncolytic virus, which has been tested in U.S. phase I and II clinical trials, is designed to replicate in target cells and kill them.
Onyx never filed for a patent on Onyx-015 in China. Nevertheless, Sunway CEO Hu Fang says that in developing H101, "we followed almost everything Onyx did in clinical trials. … We modified the virus, very little, for patent purposes."
Although Onyx-015 has shown in phase II trials that it also can achieve local shrinkage of head and neck tumors of about 60% to 70%, McCormick, a co-founder of Onyx, says this was not enough to win FDA approval. Regulators wanted more evidence, specifically data showing that Onyx-015 prolonged survival. Onyx ended a phase III trial when the main backer pulled out in 2005.
At this point, Sunway obtained exclusive worldwide rights from Onyx to use the 015 modified virus in H101. "We bought the patent from Onyx because now we want to put our drug in Europe, the United States, and Japan," says Hu. The distribution network will be ready soon, and Hu expects 2000 patients to sign up in the first year. The company is working on an improved version, H103, that includes a heat shock protein designed to attack metastatic tumors by inducing an immune response.
Different standards
The Chinese government is both an investor in and a regulator of biotech projects such as the ventures that produced Gendicine and H101. Some observers, including Norris, are concerned that the government's dual role could weaken its vigor as an enforcer of standards. He notes that "backers of these companies are high-level government officials." From 2001 to 2005, the Ministry of Science and Technology (MOST) provided $106 million to innovative drug development, some of which went to SiBiono.
SiBiono's Peng also helped write a regulatory guidebook for SFDA on evaluating cancer gene-therapy products. Leaning forward in his executive chair, Peng proudly shows off a thin pamphlet. "It's the most systematic guidelines in the world, and I was the main framer," Peng exclaims. There's an appearance of a conflict of interest in this, Norris says, although the government's acceptance of help with regulatory guidelines may reflect a wish to catch up quickly with standards in developed countries.
Peng acknowledges that SiBiono has government support and confirms that the application for Gendicine was sped "through a special channel." The data from the Gendicine trials were submitted to SFDA in March 2003; the drug was approved 7 months later. Sunway also "pushed" to get its H101 application through in 10 months, Hu confirms. But companies can also apply for accelerated review at the U.S. FDA, and Peng argues that Chinese companies must comply with strict regulations, just like their counterparts in the West.
Yin Hongzhang, SFDA's chief of biological products, says the agency has "special policies" to approve a drug on the fast track if an initial technical review looks fine. "But we would require the manufacturer to do further research and collect more data on efficacy to submit" after approval, he says. Earlier this year, he asked SiBiono to send the required follow-up data; when he spoke with Science he was still waiting for the data.
China's regulatory framework differs in another way. Whereas the U.S. FDA often requires that novel cancer drugs extend the life of the patient to be judged a success, SFDA approved both Gendicine and H101 on the basis of tumor shrinkage.
Sunway's Hu says his company intends to show that H101 increases survival as well as shrinks tumors. "Survival time for patients is very important," says Hu. In a retrospective study, he says the company has found that H101 can provide a 7-month survival benefit, but the results were not significant. They are now repeating phase III trials with a bigger sample size and more treatment cycles designed to maximize survival benefit.
There is good reason to expect that Chinese biotechnology will have a bright future. Companies in China "have excellent production facilities, a lot of money, and a lot of good people," says UW's Lieber. Zhang adds that Chinese bioscientists deserve credit for picking up U.S. pioneers' work in cancer gene therapy.
At least a half-dozen Chinese gene-therapy drugs are in clinical trials at the moment, says Savio Woo, past president of the American Society of Gene Therapy. "Before the end of this decade, they should have more drugs. I will be surprised if they didn't," he says. China also may draw significant outside investment to the field. Genzyme, for example, is negotiating to have Sunway run a phase II genetherapy clinical trial in China. The U.S. company is testing a modified adenovirus construct (Ad2/HIF-1) to promote angiogenesis in patients with peripheral arterial disease, an immobilizing condition that decreases blood flow to the muscles. Already, Genyzme has enrolled 300 patients in Europe and the United States. "The climate in China is changing, with more innovative companies not just focused on manufacturing," says Genzyme Vice President Earl Collier Jr. "We want to participate."
Zhang nevertheless worries about "media hype" that could "mislead patients, officials, and investors and cause significant damage to the further development of China's biotech industry." He hopes China can avoid repeating the mistakes that set back gene therapy in the West.
Company clarifies controversial stem cell study By Maggie Fox, Health and Science Editor
Wed Nov 22, 5:51 PM ET
WASHINGTON (Reuters) - A company scolded in Congress and criticized by religious groups for an experiment involving human embryonic stem cells clarified its work on Wednesday and said it had demonstrated an acceptable alternative to producing the controversial cells.
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Advanced Cell Technology of Worcester, Massachusetts published additional details that showed the work had yielded human embryonic stem cells without the need to harm any embryos, although several embryos were destroyed in this particular experiment.
"We've done this experiment several times now, and the embryos remain frozen in liquid nitrogen. We plan to maintain them just like they do with leftover embryos at IVF (in vitro fertilization) clinics," said Dr. Robert Lanza, chief scientist at the company.
The journal Nature published the extra details, along with a commentary calling the experiment both an advance and a potential way around objections to working with human embryonic stem cells.
Such stem cells are considered enormously powerful, because they might one day be used to regenerate body parts to treat diabetes, cancer or other conditions.
But opponents say it is unethical to experiment on human embryos. In July, U.S. President George W. Bush vetoed an expansion of federal funding for embryonic stem-cell research.
In August, Lanza's team published their study showing they had used a method already employed in fertility treatments to remove one cell from a human embryo without harming it.
When an embryo has just eight to 10 cells, one cell can be removed without harming it, and the rest can be implanted into a mother's womb to develop. Embryonic stem cells are usually taken from a later-stage embryo and the process destroys it.
BYPASSING OBJECTIONS
Lanza's team presented their work as a way to bypass objections to the research, but critics, including Richard Doerflinger of the U.S. Conference of Catholic Bishops, denounced it.
And supporters in the U.S. Congress also criticized the work, saying the company had done harm to its own case.
Lanza said he hoped publishing the details would clear up any discrepancies that critics had raised.
Dr. Joe Leigh Simpson, an expert on stem cells and human obstetrics at the Baylor College of Medicine in Texas, said the company had demonstrated that it could get stem cells without destroying embryos. "They clearly did it," he said.
"We need to get stem cells. We need to get them in the most efficacious manner," Simpson added in a telephone interview.
Simpson wrote a commentary on the work in Nature in which he said he believed most of society would eventually accept human embryonic stem cell research.
"People always oppose these kinds of technical advances at first," he said.
The method Lanza used is called pre-implantation genetic diagnosis (PGD), and it is used when a would-be parent carries a genetic disease and wants to conceive a child without it.
Egg and sperm are united in a lab dish and if an embryo starts growing, one cell is removed and tested for the genetic defect. If it is missing, the embryo is then implanted in a woman's uterus to develop normally.
Lanza hopes cells removed using this method could be used to create batches, or lines, of stem cells.
"We're also working with a couple of teams to do this in the clinical setting in conjunction with PGD," he said.
"But one of our first goals is to apply for an NIH ( National Institutes of Health) grant with our collaborators to see if the government is willing to fund researchers using stem cell lines generated without destroying the embryo.
http://news.yahoo.com/s/nm/20061122/pl_nm/stemcells_dc
Happy Thanksgiving..........May geron rock...
JJ Cale at his best............
Boilin' Pot
Now she don't know where she is, how sexy she can be
She don't realise what her eyes do to me
She keeps me hot, like a boilin' pot
She whispers in my ear, ";Let's do it right here";
The ways of a wantin' woman aren't a mystery
The style she has will never fade as long as she's havin' me
She keeps me hot, like a boilin' pot
She whispers in my ear, ";Let's do it right here";
She keeps me hot, like a boilin' pot
Burning right through the night
It don't take long for her to catch my eye
When she wants to suck me in, it's easy as pie
She keeps me hot, like a boilin' pot
Burning right through the night
Back to our regular programming...........
After midnight, were gonna let it all hang down.
After midnight, were gonna chug-a-lug and shout.
Were gonna stimulate some action;
Were gonna get some satisfaction.
Were gonna find out what it is all about.
After midnight, were gonna let it all hang down.
After midnight, were gonna shake your tambourine.
After midnight, its all gonna be peaches and cream.
Were gonna cause talk and suspicion;
Were gonna give an exhibition.
Were gonna find out what it is all about.
After midnight, were gonna let it all hang down.
After midnight, were gonna let it all hang down.
Second verse
After midnight, were gonna let it all hang down.
After midnight, were gonna let it all hang down.
After midnight, were gonna let it all hang down.
After midnight, were gonna let it all hang down.
Seeing as how george bush finally made it to vietnam i decided to dedicate this song to that useless fucking asshole..........Pardon my french.......
Potential Source of Stem Cells for Heart Repair, Other Uses Found in Fat of Elderly, Chronically Diseased Patients: Presented at AHA
CHICAGO, IL -- November 17, 2006 -- Mesenchymal progenitor (stem) cells are as plentiful in the fat of elderly and chronically diseased patients as in that of the young, healthy patients previously investigated.
Paul DiMuzio, MD, assistant professor, departments of surgery and of radiology, Thomas Jefferson University, Philadelphia, Pennsylvania, and colleagues reported the findings here at the American Heart Association (AHA) 2006 Scientific Sessions.
Cells of this type have shown promise for reducing the long-term impact of myocardial infarction according to other research presented this year at the AHA meeting and can also be used to produce tissue-engineered blood vessels for later implantation. In remarks to reporters at the scientific sessions, Dr. DiMuzio noted that availability of progenitor cells from bone marrow and similar sources tends to decrease in older patients -- precisely the ones most likely to need cardiovascular repair.
A mean of 15 g of fat was obtained by liposuction from 49 patients undergoing various elective vascular procedures. After digestion with collagenase I, differential centrifugation was used to separate a stromal-vascular pellet from mature adipocytes and the pelleted cells were plated out on culture medium. After 7 days of culture, cells displaying markers for undesired cell types were removed and the number of adipose-derived stem cells (ASCs) was determined. The ASC preparation was > 98% pure by flow cytometry.
The number of stromal-vascular cells and ASCs was analyzed by patient subgroup. No effect of age, gender, or presence of peripheral vascular disease was seen. Body mass index increased the yield of stromal vascular cells but not of ASCs. Diabetes mellitus and end-stage renal disease decreased the yield of stromal-vascular cells but only diabetes decreased the yield of ASCs.
Isolated ASCs appeared normal when analyzed by light microscopy and their ability to proliferate was normal, but their ability to differentiate has not yet been tested. Dr. DiMuzio's group is primarily interested in their ability to differentiate into endothelial cells that could be used to create new blood vessels.
The authors concluded, "The use of adipose tissue as a source of adult stem cells in elderly patient with vascular disease appears initially viable."
http://www.docguide.com/news/content.nsf/news/852571020057CCF685257229005A86CB
Introgen Licenses Nanoparticle Patents
Thursday November 16, 10:10 am ET
Introgen Therapeutics Licenses Nanoparticle Patents From University of Texas
AUSTIN, Texas (AP) -- Biopharmaceutical company Introgen Therapeutics Inc. said Thursday it obtained exclusive rights to a portfolio of patents from the University of Texas M.D. Anderson Center, focusing on nanoparticles.
The patents deal with nanoparticles that can deliver therapeutic bioactive proteins and other compounds to cells, including cancer cells. The goal is for the nanoparticles to increase a treatment's activity and more specifically target cells.
Financial details of the agreement were not disclosed.
The company already has previous agreements with the Anderson Cancer Center. The University of Texas Board of Regents owns stock in Introgen.
Introgen has three nanoparticle product candidates in development, with the most advanced in Phase I clinical trials for metastatic lung cancer.
Shares of Introgen rose 5 cents to $4.70 on the Nasdaq in morning trading.
http://biz.yahoo.com/ap/061116/introgen_patents.html?.v=1
Stem cells help dogs with dystrophy By MALCOLM RITTER, AP Science Writer
1 hour, 44 minutes ago
NEW YORK - Stem cell injections worked remarkably well at easing symptoms of muscular dystrophy in a group of golden retrievers, a result that experts call a significant step toward treating people.
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"It's a great breakthrough for all of us working on stem cells for muscular dystrophy," said researcher Johnny Huard of the University of Pittsburgh, who wasn't involved in the work.
Sharon Hesterlee, vice president of translational research at the Muscular Dystrophy Association, called the result one of the most exciting she's seen in her eight years with the organization. Her organization helped pay for the work.
She stressed that it's not yet clear whether such a treatment would work in people, but said she had "cautious optimism" about it.
Two dogs that were severely disabled by the disease were able to walk faster and even jump after the treatments.
The study was published online Wednesday by the journal Nature. It used stem cells taken from the affected dogs or other dogs, rather than from embryos. For human use, the idea of using such "adult" stem cells from humans would avoid the controversial method of destroying human embryos to obtain stem cells.
The Nature paper focuses on Duchenne muscular dystrophy, a muscle-wasting genetic disorder that affects only boys and occurs in about 1 in every 3,500 male births. It's the most severe and most common childhood form of muscular dystrophy and the best-known. In theory, the stem cell treatment might also help other muscle dystrophies or even age-related muscle wasting, Hesterlee said.
Boys with Duchenne dystrophy have trouble walking as early as preschool, and nearly all of them lose their ability to walk between ages 7 and 12. Typically, they die in their 20s because of weakness in their heart and lung muscles. There is no known cure.
The dog study was done by Giulio Cossu, director of the Stem Cell Research Institute at the San Raffaele Scientific Institute of Milan in Italy, with colleagues there and elsewhere.
"We do not know whether this will work in patients," Cossu said in a telephone interview. He said he hopes to start a small experiment in children in the next year or two.
The scientists worked with golden retrievers that suffer a crippling form of dystrophy very much like the human one. Researchers studied the effect of repeated injections into the bloodstream of a kind of stem cell extracted from blood vessel walls.
The best results appeared when the cells were taken from healthy dogs. But Cossu said scientists should pursue the possibility of genetically manipulating a patient's own cells and using them instead. That way, patients wouldn't have to undergo lifelong treatment to avoid rejection of donated cells.
In one of several experiments, three dogs that had not yet shown impairment in walking were injected five times, a month apart, with cells taken from other dogs.
One dog completely avoided symptoms and continued to walk well even five months after both the injections and the anti-rejection therapy were stopped.
A second dog also did well initially but died suddenly of a heart problem after just two months on the treatment. It's not clear whether the problem had anything to do with the treatment, or whether the initial good result would have continued, Cossu said.
The third dog showed partial protection, being able to walk and even run with a limp, but then progressively lost walking ability within a few days after the anti-rejection treatment was stopped.
The researchers also treated two dogs that were severely impaired by the disease. Both gained the ability to move much faster and to jump, and one was even able to run, although neither could use the hind legs normally.
One of these dogs rapidly lost walking ability when the anti-rejection treatment was stopped, but the other continued to walk well for five months until succumbing to pneumonia. That's a common fate for dogs with the genetic condition because of weakness in breathing muscles.
Cossu said he believed that a human treatment could be directed more at breathing muscles than it was in the dogs.
The cells helped strengthen muscle by fusing with regenerating muscle fibers.
___
http://news.yahoo.com/s/ap/20061115/ap_on_he_me/stem_cells_dystrophy
Heart valves grown from womb fluid cells By LINDSEY TANNER, AP Medical Writer
14 minutes ago
CHICAGO - Scientists for the first time have grown human heart valves using stem cells from the fluid that cushions babies in the womb — offering a revolutionary approach that may be used to repair defective hearts in the future.
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The idea is to create these new valves in the lab while the pregnancy progresses and have them ready to implant in a baby with heart defects after it is born.
The Swiss experiment follows recent successes at growing bladders and blood vessels and suggests that people may one day be able to grow their own replacement heart parts — in some cases, even before they're even born.
It's one of several sci-fi tissue engineering advances that could lead to homegrown heart valves for infants and adults that are more durable and effective than artificial or cadaver valves.
"This may open a whole new therapy concept to the treatment of congenital heart defects," said Dr. Simon Hoerstrup, a University of Zurich scientist who led the work, which was presented Wednesday at an American Heart Association conference.
Also at the meeting, Japanese researchers said they had grown new heart valves in rabbits using cells from the animals' own tissue. It's the first time replacement heart valves have been created in this manner, said lead author Dr. Kyoko Hayashida.
"It's very promising," University of Chicago cardiologist Dr. Ziyad Hijazi said of the two studies. "I don't doubt" that it will be applied one day in humans, he said.
One percent of all newborns, or more than 1 million babies born worldwide each year, have heart problems. These kill more babies in the United States in the first year of life than any other birth defects, according to the National Institutes of Health.
Heart valve defects can be detected during pregnancy with ultrasound tests at about 20 weeks of pregnancy. At least one-third of afflicted infants have problems that could be treated with replacement valves, Hoerstrup said.
"It could be quite important if it turns out to work," said Dr. Robert Bonow, a Northwestern University heart valve specialist.
Conventional procedures to fix faulty heart valves all have drawbacks. Artificial valves are prone to blood clots and patients must take anti-clotting drugs for life. Valves from human cadavers or animals can deteriorate, requiring repeated open-heart surgeries to replace them, Hijazi said. That's especially true in children, because these valves don't grow along with the body.
Valves made from the patient's own cells are living tissue and might be able to grow with the patient, said Hayashida, a scientist at the National Cardiovascular Center Research Institute in Osaka.
The Swiss procedure has another advantage: using cells the fetus sheds in amniotic fluid avoids controversy because it doesn't involve destroying embryos to get stem cells.
"This is an ethical advantage," Hoerstrup said at the meeting.
Here's how the experiment worked:
Amniotic fluid was obtained through a needle inserted into the womb during amniocentesis, a prenatal test for birth defects that is often offered to pregnant women aged 35 and older.
Fetal stem cells were isolated from the fluid, cultured in a lab dish, then placed on a mold shaped like a small ink pen and made of biodegradable plastic. It took only four to six weeks to grow each of the 12 valves created in the experiment.
The researchers said lab tests showed they appeared to function normally.
The next step is to see if they work in sheep, a two-year experiment that Hoerstrup said is under way.
He and co-researcher Dorthe Schmidt called their method "a promising, low-risk approach enabling the prenatal fabrication of heart valves ready to use at birth."
Hoerstrup said amniotic stem cells also can be frozen for years and could potentially be used to create replacement parts for aging or diseased valves in adults, too.
The research is preliminary and experts say implanting tissue-engineered human valves in human hearts is likely years away. But it's not as far-fetched as it sounds.
Earlier this year, U.S. scientists reported re-engineering seven diseased bladders with tissue grown from the patients' own cells.
And last year, researchers reported that two kidney dialysis patients from Argentina had received the world's first tissue-engineered blood vessels, fashioned from their own skin and vein tissue.
Dr. John E. Mayer Jr., a Children's Hospital Boston heart surgeon and tissue engineering pioneer, said scientists are optimistic that this area of research will revolutionize how people with valve disease will be cared for in the future.
About 250,000 patients worldwide have surgery to replace heart parts each year, according to Mayer.
In one of Mayer's experiments, heart valves fashioned from stem cells harvested from sheep bone marrow appeared to function normally when implanted in sheep. A similar experiment used cells harvested from sheep arteries.
Hoerstrup said amniotic fluid is potentially a richer source of stem cells than other sources.
Mayer said the big question is whether stem cells from amniotic fluid can create valves superior to those made from other cell types.
"I'm pretty sure the ball will continue to be advanced down the field," Mayer said. "We'll get there one way or the other."
http://news.yahoo.com/s/ap/20061115/ap_on_he_me/growing_heart_valves
Strong Leonid Meteor Shower Expected This Weekend Robert Roy Britt
Senior Science Writer
SPACE.com
Tue Nov 14, 3:15 PM ET
The annual Leonid meteor shower could produce a strong outburst this weekend for residents of the North America and Western Europe.
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A brief surge of activity is expected begin around 11:45 p.m. ET Saturday, Nov. 18. In Europe, that corresponds to early Sunday morning, Nov. 19 at 4:45 GMT. The outburst could last up to two hours.
At the peak, people in these favorable locations could see up to 150 shooting stars per hour, or more than two per minute.
"We expect an outburst of more than 100 Leonids per hour," said Bill Cooke, the head of NASA's Meteoroid Environment Office. Cooke notes that the shooting stars during this peak period are likely to be faint, however, created by very small meteoroid grains.
Elsewhere people will see the typically enjoyable Leonid display of a few meteors each hour, weather permitting and assuming dark skies away from city lights [Top 10 Leonids Facts].
Ancient debris
The Leonids are bits of debris left behind by repeated passages through the inner solar system of the comet Tempel-Tuttle. Each November, Earth crosses various trails of debris, which have spread out over centuries and millennia. Dense debris trails have caused incredible meteor storms in years, past, notably 1998 through 2002 [Images from 2001: Gallery 1, 2, 3, 4].
Since then the show has been back to normal. But recent computer modeling suggests a brief outburst.
"For parts of Europe, Africa and eastern North America, a far more prolific Leonid show could be in the offing this year," said Joe Rao, SPACE.com's Skywatching Columnist.
This year is not expected to be as memorable as some but well worth a look, astronomers say. The Leonids are known for producing bright fireballs, which could occur at any time.
The Leonids are so-named because they appear to emanate from Leo. The meteors can race across the sky in any direction, but trace each one back and it'll point to Leo.
Other opportunities
Unfortunately for viewer's on the U.S. West Coast, the peak occurs before Leo rises. Outside of the expected peak, the best time to watch for Leonids is in the pre-dawn hours, when the constellation Leo is high in the sky.
The Leonids are actually underway already, ramping up gradually to the peak. The event continues for several days after the peak. So any morning during this time could offer up a handful of meteors each hour. Other shooting stars from other sources typically grace the sky at low rates, too.
Flurries of enhanced activity can come at any time. Cooke suggests taking a look in the pre-dawn hours Friday, Saturday and Sunday. Up to 10 shooting stars per hour are possible any of these mornings.
How to watch
Precise prediction of meteor showers is an infant science, so those in position to observe the possible outburst should plan to head out a half-hour before the predicted peak, allowing eyes time to adjust to the dark, and stay out for up to a half hour after the expected peak.
No special equipment is needed. Telescopes and binoculars are of no use.
A lounge chair or blanket and warm clothes are all you need [meteor watching tips]. Find a dark location with a clear view of the Eastern horizon. Lie back, face East, and scan as much of the sky as you can . You never know exactly where a Leonid will appear.
Top 10 Leonid Meteor Shower Facts
Meteors and Meteor Showers: How They Work
Shooting Star Reflections: The Leonid Meteor Storm of 1966
Does Anyone Ever Get Hit by Meteors?
Tips on Meteor Shower Photography
Comets, Meteors & Myth
Original Story: Strong Leonid Meteor Shower Expected This Weekend
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Researchers spur growth of adult brain stem cells
Tue Nov 14, 2006 10:13 PM GMT
Email This Article | Print This Article | RSS [-] Text [+] By Will Dunham
WASHINGTON (Reuters) - Researchers have found a way to spur the growth of neural stem cells in the brains of adult mice with an eye towards harnessing the brain's innate capacity for repair to help people with diseases such as Alzheimer's.
Determining how these stem cells can be deployed to replace cells in mice whose brains are damaged in ways resembling Parkinson's disease, Alzheimer's disease and multiple sclerosis in people is the next key step, researchers said.
The study, appearing on Tuesday in the Journal of Neuroscience, provides a fresh example of the potential for using so-called adult stem cells to treat illness by replacing cells damaged by disease or injury.
But Paul Patterson of the California Institute of Technology, senior author of the study, said it is important for scientists to continue to study embryonic stem cells as well.
Patterson and colleague Sylvian Bauer injected a natural protein from the body -- leukaemia inhibitory factor, or LIF -- into a part of the brain of adult mice where stem cells reside. This fostered the production of up to six times the usual count of adult neural stem cells.
Using a person's own cells, rather than foreign cells, in future regenerative therapies avoids the transplantation of stem cells that the body's immune system might reject.
While this study involved mice, the researchers noted that human adults also harbor neural stem cells in their brains. The brains of neurodegenerative disease patients appear to try to marshal their own neural stem cells to replace dying cells, but not in the numbers sufficient to do the job.
"The adult brain does try to repair itself by stimulating its own neural stem cells. But obviously it's not enough. So what we're trying to do here is kick it in the pants and increase the number of neural stem cells," Patterson said in an interview.
Stem cells are a kind of master cell for the body, producing various tissue and cell types. If researchers can figure out how to control them and direct them into changing into specific types as needed, stem cells might be able to replace tissue harmed by illness or injury.
Those taken from days-old embryos are especially malleable, and can produce any cell or tissue found in the body, but so-called adult stem cells also have shown promise.
Some people oppose as unethical the use of cells from human embryos in research, arguing that good research can be done using adult stem cells. Scientists are trying to develop potential treatments using both kinds of cells.
Patterson said possible human therapies related to his research remain years away. He emphasized the importance of scientists pursuing work on adult and embryonic stem cells as they try to realise the potential of regenerative therapies.
"My own feeling is that lots of different approaches should be tried simultaneously because we don't know which ones are going to be the most successful. So we have to push on all fronts," Patterson said.
http://today.reuters.co.uk/news/articlenews.aspx?type=topNews&storyID=2006-11-14T221251Z_01_N143...
Seaweed extract stops stem cell tumours
November 14, 2006 12:00
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A SEAWEED extract can overcome a problem that can be sparked when embryonic stem cells are implanted in humans, Australian scientists say.
Researchers at the University of NSW have worked out how to prevent the cells from forming tumours when they are injected into the body.
The answer was to encase each cell in a tiny capsule made from a seaweed extract called alginate before transplantation, said Professor Bernie Tuch, study leader and director of the university's diabetes transplant unit.
"Whilst embryonic stem cells have great potential to deliver therapies for disorders, such as diabetes, a fear has been that they will form tumours because of the presence of undifferentiated cells," Prof Tuch said.
"Our breakthrough removes what could have been a stumbling block to this vital research."
The research team used both human and mouse embryonic stem cells to experiment with the capsules, which naturally allow nutrients in but block problematic cells.
This stops the embryonic cells from producing non-malignant tumours, called teratomas, and also prevents the cells from being rejected.
The advance, published today in the journal Transplantation, comes as the Senate last week voted to lift a ban on therapeutic cloning, a step Prof Tuch called "very encouraging".
The therapeutic cloning issue still needs to be debated by the House of Representatives.
The research team is already using the technology to transplant insulin-producing cells from donors into insulin-dependent diabetic people without using anti-rejection drugs.
The trial involving six diabetics is expected to be completed by mid-2008.
http://www.news.com.au/dailytelegraph/story/0,22049,20754877-5001028,00.html
German scientists urge review of stem cell laws Fri Nov 10, 12:25 PM ET
BERLIN (Reuters) - German scientists on Friday called on the government to change the country's laws on the production of stem cells to enable experts to keep up with global advances in research.
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Genetic research is a sensitive subject in Germany due to Nazi experiments to create a master race and the country has strict laws on stem cell research.
Germany's influential DFG institute of scientists focused mainly on a decision by the German parliament in 2002 which controls the import of embryonic cells from pre-existing stem lines and bars their production in the country.
"The 2002 law means German scientists are largely denied access to new stem lines and unable to work in international projects," the institute said in a statement. "It should be abolished."
The DFG said new cell lines, available in foreign stem cell banks, allow research to take place at an international level.
"But German scientists are banned from using them."
The institute said German researchers should be allowed access to newer stem cells produced overseas and that Germany should permit the introduction of cell lines for diagnostic, preventative and therapeutic purposes.
It also said researchers should not be threatened with punishment for breaking the rules.
The DFG, which reiterated its opposition to reproductive cloning, said it published its recommendations to stimulate debate in Germany.
German Research Minister Annette Schavan, however, rejected the demand.
"With the (2002) cut-off date we can be sure there is no pressure from Germany to destroy embryos," she said, adding, however, that she would look at lifting the threat of punishment for scientists working on international projects.
Many scientists argue that German researchers are losing out to counterparts in other countries such as Britain which allows therapeutic cloning, or the creation of embryos as a source of stem cells to cure diseases.
Some researchers hope that U.S. embryonic stem cell research restrictions may ease after Democrats won control of Congress in this week's mid-term elections.
Stem cells can develop into different cell types such as blood, brain and bone. Researchers say they offer the potential to treat conditions such as diabetes and Parkinson's disease and to regenerate damaged organs or tissue.
However, those who believe life begins at conception say the cells should be harvested from adults and not from embryos.
http://news.yahoo.com/s/nm/20061110/sc_nm/stemcells_germany_dc
President George W. Bush Cloned
Written by Gnarly Erik
Story written: 10 November 2006
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Artist's Impression: They had hoped for so much more Washington, DC, 11/10/06 (Rioters News Service): Scientists today announced the first known cloning of a Human being. Due to the highly controversial nature of this experimental process, the tests were done in a secret location in rural Maryland.
"We knew this was theoretically possible." said a spokesman for the cloning team. "But, it's an understatement to say we are blown away by the final results."
In a bombshell announcement specialists also revealed the donor for the clone was none other than US President George W. Bush. Experts on cloning were astonished that the president agreed to be the donor as 'he is so dead set against stem cell research and very idea of cloning.' in the words of one expert.
However, a member of the medical team said Bush likely wished to leave behind a better personal legacy to offset the disaster he's made of his presidency. "President Bush also feels that his participation in this experiment will help moderate the hatred felt for him from all other political spectrums. He must be applauded for his courage." he said.
Another major surprise is the surrogate mother chosen to carry the cloned fetus to term was Ann Coulter, the well known radical right wing columnist. "Her reputation needed quite a bit of help too." said a spokesman. "And, why not kill two birds with one stone? In fact, Ms. Coulter made an excellent surrogate after extensive treatment for her bulimia and obvious emaciation."
But, the experts saved the major bombshell for last when they unveiled the tiny new baby. The cloning team said ultrasounds prior to birth had already revealed the baby would likely be very unusual. However they were completely unprepared for what they saw when Ms. Coulter gave birth.
"During the delivery, we were speechless to see a healthy, fully developed, and very lovable Beagle puppy emerge!" said a team member. "We thought there must be some mistake or some bad joke somehow, but extensive testing indicates the baby is an exact clone of George W. Bush, down to his personality and verbal abilities."
"Tests indicate the DNA is an exact match. At this point we simply do not understand how this came to be."
"As you can imagine we are doing all sorts of additional testing and undoubtedly will discover exactly what occurred. Mother and baby are both doing just fine, although Ms. Coulter has needed a great deal of continuing encouragement to keep her breast feeding the baby."
President Bush has not been seen in public since the birth of the clone and has had no announcement. Presidential spokesman Tony Snow claimed to know nothing about the cloning remarking, "It might be like all those missing WMDs - just figments of the imagination."
http://www.thespoof.com/news/spoof.cfm?headline=s5i12038
Sector Wrap: Election boosts Stem Cells
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NOV. 10 3:16 P.M. ET Stem cell research attracted some post-election attention this week after Missouri voters narrowly passed a state constitutional amendment protecting federally allowed research.
The narrow vote, carried by mostly urban Missourians, came as the Democrats completed a sweep of both chambers of Congress. Analysts have said that stem-cell research could be further promoted now that Democrats have congressional control.
Though several companies, including Palo Alto, Calif.-based StemCells Inc. and Menlo Park, Calif.-based Geron Corp. caught an initial boost from the results, shares settled back down by late Thursday. The election results are not likely to end the debate over the research or significantly change funding regulations in the near-term. But analysts have said the election results could start to shift the dynamic.
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The results amounted to good news for Carlsbad, Calif.-based Invitrogen Corp, according to Bank of America analyst Frank H. Pinkerton, citing that company's relationship with Geron. Invitrogen makes kits used by researchers for gene cloning and has licensed patents from Geron.
"Invitrogen, an undervalued stock in need of positive news, found a fundamental catalyst with the election result, as several tight elections are tending to favor candidates in favor of stem cell research," he wrote in a note to investors.
The news also was welcomed by Alameda, Calif.-based Advanced Cell Technology Chief Executive William M. Caldwell. It's been a tough road for companies working on stem cell-based therapies because of the funding issues, he said, and the perceived shift this week could give them the support they need to push forward by eventually removing some barriers.
"A company like ours has got to be driving to make what science we have and transfer it into therapeutics," he said.
Advanced Cell made a splash in August when it revealed it developed a technique to grow stem cells from a single cell taken from a human embryo. Much of the debate around stem cells focuses on the technique in which cells are taken from embryos prior to the embryo being destroyed. The technique revealed in August takes a stem cell from a cluster of cells before that cluster is implanted in a woman's uterus as part of in vitro fertilization.
Caldwell said much of the funding initiative has fallen to state governments. Advanced Cell even moved its headquarters from
http://www.businessweek.com/ap/financialnews/D8LADSI00.htm
Cured by your own stem cells
Created: Thursday, November 09, 2006
A study to determine if heart attack patients can be treated with injections of their own bone marrow stem cells is being conducted by researchers in the United Kingdom.
The trial of 100 people will assess the effects of injecting the stem cells within five hours of a heart attack, BBC News reported.
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There is evidence to suggest that bone marrow stem cells can help repair heart muscle damage caused by a heart attack. This kind of repair could help prevent subsequent heart failure in heart attack patients.
Stem cells are immature cells that can develop into any kind of tissue.
The study, funded by the UK Stem Cell Foundation, will be run by Barts Hospital in London. Patients in the study will receive both the stem cell injections and angioplasty, a procedure to clear blocked arteries, BBC News reported.
"If we can demonstrate improvement in quality of life of patients then this will be a significant step forward in the treatment of heart disease," said researcher Dr Anthony Mathur. "Because the stem cells are taken from the patient themselves there are minimal ethical issues surrounding this procedure. There is also less likelihood of rejection complications." – (HealthDayNews)
http://www.health24.com/news/Genetics/1-916,38264.asp
Vaccination With Embryonic Stem Cells Prevents Lung Cancer In Mice
Researchers in America have discovered that vaccinating mice with embryonic stem cells prevented lung cancer in those animals that had had cancer cells transplanted into them after the vaccination or that had been exposed to cancer-causing chemicals.
The findings suggest that it could be possible to develop embryonic stem cell vaccines that prevent cancers in humans, such as hereditary breast and colon cancer and lung cancer caused by smoking or other environmental factors.
Professor John Eaton told a news briefing at the EORTC-NCI-AACR [1] Symposium on Molecular Targets and Cancer Therapeutics in Prague today (Wednesday 8 November): "We found that the vaccinations were between 80-100% effective in preventing tumour growth in mice that were subsequently challenged with transplanted Lewis lung carcinoma, and it was between 60-90% effective in mice subsequently exposed to carcinogens that cause lung cancer.
"Our results raise the exciting possibility of developing a prophylactic vaccine capable of preventing the appearance of various types of cancers in humans, especially those with hereditary, chronological or environmental predispositions to neoplastic disease."
However, he warned that the work was still in its early stages and that people should not think that, for instance, they could start, or carry on, smoking because a vaccine to prevent lung cancer was just around the corner.
"Cancer has been prevented and even cured in mice hundreds of times. At present, all I can say is that so far it looks good, and that, unless something unexpected happens, this strategy might some day be applied to humans at high risk for development of cancer. The likelihood of this happening is more a question for the US Food and Drug Agency than for us. Given their stringent regulations I consider it quite likely that, by the time this is tried in humans, I will be pushing up daisies."
Prof Eaton is the James Graham Brown Professor of Cancer Biology and Deputy Director of the James Graham Brown Cancer Center, University of Louisville, USA. He and his colleague, Dr Robert Mitchell, tested two different vaccines in the mice. One consisted of embryonic stem cells (ESC) only, obtained from mouse blastocysts (very early, pre-implantation embryos). The other vaccine consisted of the ESCs combined with cultured fibroblast cells producing GM-CSF, a growth factor usually made by white blood cells and blood vessel-lining endothelial cells, which "supercharges" the immune response and appears to enhance the vaccine-induced immunity to cancer.
Prof Eaton explained: "We needed a delivery vehicle for GM-CSF and chose STO fibroblasts because they are often used as a 'feeder layer' to maintain these particular mouse embryonic stem cells in their embryonic state. If we had used only ESCs expressing GM-CSF, they might have differentiated into non-embryonic cells, which, therefore, would not have worked as a vaccine."
He and his team injected mice with ESCs alone or ESCs + STO/GM-CSF. In mice that had Lewis lung carcinoma transplanted into them afterwards, ESCs were 80% effective in preventing tumour growth and ESCs + STO/GM-CSF were 100% effective. In mice subsequently exposed to a carcinogen that causes lung cancer (3-methylcholanthrene followed by repetitive dosing with butylated hydroxytoluene), ESCs resulted in 60% of mice remaining tumour free after 27 weeks and ESC + STO/GM-CSF resulted in 90% remaining tumour free. Importantly, tumours arising in vaccinated mice were, on average, about 80-90% smaller than tumours in unvaccinated mice. All the unvaccinated mice developed tumours. None of the vaccinated mice developed autoimmune disease or a showed a significant decline in adult pluripotent bone marrow stem cells -- both potential adverse responses to the vaccinations.
Prof Eaton said: "We think the results from the carcinogen-initiated cancers are probably the most important, as they are closer to the 'real-life' model of the development of cancer than just implanting cancer cells in an animal. We are studying several different types of carcinogen-induced mouse cancers (skin, colon, breast) to determine whether the preventative effect of vaccination extends beyond our models of lung cancer (although in our state of Kentucky with its high smoking rates, lung cancer alone would be a big victory). We may also vaccinate ageing rodents, the majority of which develop endocrine tumours in old age.
"In terms of human testing, if all goes well, then I think this vaccination might best be tested in women at high (genetic) risk of breast cancer, in people with high (genetic) risk of colon cancer and, perhaps, in smokers.
"Our progress over the next few years will depend, to a large extent, on whether we can attract significant funding. Our work is presently supported by a pilot grant from our cancer centre and a small grant from the Kentucky Lung Cancer Research Program. US federal funding agencies such as the NIH -- notorious for funding predictable research -- have been quite disinterested."
http://www.sciencedaily.com/releases/2006/11/061108101513.htm