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Editor: Katharine Van Tassel
Akron Univ. School of Law

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Tuesday, March 18, 2008

Better Vision Through Stem Cells?

National Public Radio's Morning Edition had an interesting piece this morning on the use of stem cells in China to improve the vision of a number of blind children.   It sounds like a new frontier in medicine - unfortunately without the appropriate testing and protective standards we would hope to see - especially when dealing with children.  The background piece states,

China is gaining popularity among a new breed of travelers: patients with incurable conditions who are visiting the country to receive experimental stem-cell treatments not offered in the United States. One company is now claiming a medical breakthrough, advertising that its treatments are restoring vision to blind children. It has ignited a firestorm of controversy in both China and in the U.S.

Giving Parents a New Option

Jena Teague and her husband Terry Williams are among these new visitors. They traveled to China to seek stem-cell treatment for their blind, 7-month-old baby daughter, Laylah. She was born with optic nerve hypoplasia, or ONH — when the optic nerves fail to develop properly in the womb. Conventional medicine offers no treatment and no cure.  But Teague came across a Web site about stem-cell treatments offered by Beike Biotechnology in China and decided to try it — against advice from specialists at home in Georgia.  "None of the specialists had heard of the stem cells, of what they're doing here. They didn't believe it would work. They told me not to expect anything to happen out of it," Teague says. . . . . They are spending $23,000 for Laylah to have infusions of stem cells harvested from umbilical cords — not the more controversial embryonic stem cells. In the U.S., cord blood stem cells are used for treating blood diseases, but are not used for treating other conditions, such as Laylah's vision problem.

Treatment Seems to Yield Positive Results

After three sessions, Teague and Williams say the therapy is already working.  The doctors have told Laylah's parents that the baby now sees light through one eye, while the other eye is dilating almost to the point where she can see light.  So far, 10 patients suffering from ONH have received the same stem-cell treatment in China, and doctors there claim that the vision of all 10 improved after the therapy.  Dr. Shalesh Kaushal, an eye specialist at the University of Florida, . . . . is now evaluating other patients before and after the stem-cell treatment. But he is not recommending that patients go to China; he says much more research needs to be done.  "It's clearly a provocative result. … If this is a real, reproducible observation or effect in other patients, one may consider it as a fundamental breakthrough," says Kaushal.

Reasons for Improvements Remain a Mystery

Dr. Sean Hu, the 40-year-old chairman of Beike Biotechnology, is a medical doctor-turned-entrepreneur with a doctorate in biochemistry from a Swedish university.  Less than three years ago, he set up Beike. Since then, 3,000 patients — most of them from China — have received Beike's stem-cell treatments for a wide range of conditions. He says 70 percent have seen improvements, but he admits he can't explain why.  "In the clinical areas, we know there are improvements. We don't know the mechanism behind it," Hu says.

That raises many concerns. Any improvement could be due to the placebo effect — or other factors besides the stem-cell therapy — and may not lead to longer-term functional gains. No rigorous, controlled clinical trials were carried out before the treatment was offered to patients. No research has yet been published in established peer-review journals overseas. And no one knows for sure what the possible risks might be.  But Hu isn't worried by the ethical implications of what he's doing.  "I can say I changed the life of these patients. Now they get their vision back. They went from completely blind, now they can see stuff. You think that's ethical or nonethical?" he asks.

Therapies Criticized as 'Extreme Nonsense'

Beike claims to treat a wide range of conditions with stem-cell therapy — from spinal-cord injuries to epilepsy to cerebral palsy to neurodegenerative disorders. But critics have their doubts.

Bruce Dobkin is director of the neurologic rehabilitation and research program at the University of California, Los Angles. In response to questions from NPR, he writes in an e-mail that "it is extreme nonsense to think that cells can be incorporated into the complex nervous system and do so much, when we cannot even get cells in mice and rats to do very much."

Chinese scientists are worried, too.  Dr. Naihe Jing is the deputy director of one of China's top stem-cell research labs and a member of the prestigious Chinese Academy of Sciences. He fears Beike could ruin the reputation of China's entire biotech industry. "We think money is mainly behind this," he says, adding that he is concerned that one company's pursuit of profit will create a bad reputation for the whole country.

Providing Help, Providing Hope

Already, 600 foreigners have come to China and paid about $20,000 each for the stem-cell therapy, while even more Chinese patients are flocking for treatment.  The venture capital is flooding in, too. Hu, Beike's chairman, says he has raised about $15 million in funding, although NPR could not verify the claim. He admits making a calculated decision to go into stem-cell research: As he puts it, you have to choose the area with the best return. . . . .

The results of Beike's experimental therapy may be uneven and unproven. Yet for patients and their families, hope is, perhaps, the most important commodity on sale in China — even if it costs tens of thousands of dollars.

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