In January, recognizing the worsening situation, the health ministry announced a package of rules for the industry. Organizations using stem cells must register their research and clinical activities, the source of the stem cells and ethical procedures. The ministry asked local health authorities to halt any unapproved clinical use of stem cells in their regions. And it called for a nationwide moratorium on new clinical trials for stem-cell therapies, adding that patients in existing clinical trials should not be charged.
So far, however, the ministry's clampdown has proved ineffective. According to a Ministry of Health spokesman, not one clinic has registered in the required way, and Nature has found that many stem-cell clinics continue to offer treatments. Shanghai WA Optimum Health Care, for example, which has plush headquarters in a gated estate in one of the wealthiest areas of central Shanghai, claims success in using stem cells derived from umbilical cord or adipose tissue to treat a range of disorders, from autism to multiple sclerosis. Tony Lu, a member of the company's science and technology board, says that four to eight injections of such cells can treat Alzheimer's disease, at a cost of 30,000-50,000 renminbi (US$4,750-7,900) per injection. According to the company's senior patient-liaison officer, Karina Grishina, autism can be treated with an adipose-tissue-derived cell injection for 200,000 renminbi, followed a few days later by a 50,000-renminbi injection of umbilical cord cells.
[One Shanghai clinic] also lists Li Lingsong, director of the Peking University Stem Cell Research Center, as a member of its science and technology board. Li denies this. "I have so far nothing to do with WA," he told Nature, adding that he has asked the company to remove his name. WA also claims a strategic alliance with Harvard Medical School, although neither the medical school nor the Harvard Stem Cell Institute is aware of any such connection. Likewise, the University of California, Irvine, where WA claims to have research facilities, denies any formal relationship.
Dr. Irving Weissman of the ISSCR called the draft "a clever way around the FDA's appropriate role overseeing clinical trials." Weissman, director of Stanford University's Institute for Stem Cell Biology and Regenerative Medicine, said the policy violates the ISSCR's guidelines for clinical use of adult stem cells.
I, for one, am very interested to see what happens next both here and abroad.