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Regenerative Medicine to Be a $20 Billion Industry by 2025

by Brendon Nafziger, DOTmed News Associate Editor | April 22, 2010

Though China has many biotech scientists at the forefront of their field, it has to overcome a questionable reputation in stem cell therapy, a kind of regenerative medicine technique using uncommitted "stem" cells and directing them to grow into a specific kind of tissue.

Since the beginning of the last decade, controversial stem cell therapy clinics have sprouted up across China, offering treatment to medical tourists that many experts consider little better than quackery. There are now around 100 to 150 such clinics in China, according to the journal Nature, where patients, many from Europe and the United States, fly out to receive stem cell injections forbidden in their home countries.

The clinics use a mix of "autologous" adult stem cells, cells taken from donated umbilical cords and those harvested from aborted fetuses, furthering the ethical objections.

The therapies are pricey, with some costing upward of $25,000.

The operators of the clinics claim to have helped with everything from diabetes and autism to spinal cord injuries. But it is these broad claims that have provoked widespread skepticism and disbelief.

"Our opinion is the scientific data is very, very sketchy. They're talking about a lot of success, but not talking about a lot of failures, a lot of unforeseen side effects," says Ahmed.

Similar centers can be found in other parts of the world, such as Brazil and the Ukraine. There's even one in Dusseldorf, Germany.

In May 2009, China tried to toughen previously weak regulations, requiring clinics to submit evidence of safety and clinical effectiveness for all treatments, but it's not clear if this has done anything to change their practices.

"They're putting up some restrictions, but the bar is pretty low," says Ahmed.

Still, the clinics appear to be doing a booming business. On one hand, Ahmed says it's a good sign, as it indicates interest in the field of regenerative medicine. But on the other hand, because of the poor reputation and lack of widely accepted clinical evidence, it could be a looming disaster.

"It will just take one high-profile incident to put the whole field in jeopardy," he says. He hopes the field avoids the fate of gene therapy, which temporarily got "starved" of capital funding after a widely publicized case in France eight years ago where two children receiving experimental gene therapies for severe immune disorders (known as "bubble boy" syndrome) developed leukemia-like illnesses after the treatment.

"The whole field just completely fizzled even though the science was there," Ahmed says. "You can't push these things faster than they need to be."

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