In July 2008, the FDA told Regenerative Sciences that its treatments are drugs according to the Federal Food, Drug and Cosmetic Act, and biological products under the Public Health Service Act. But the company did not apply for FDA approval and continued to offer the treatment. Now the agency says that the company is not following good manufacturing practice, and that the treatment's safety and efficacy is unproven.
But Christopher Centeno, Regenerative Sciences' medical director, argues that as the treatment uses a patient's own stem cells, it is a medical procedure akin to in vitro fertilization, and therefore none of the FDA's business. He adds that his treatment has a much better safety record than conventional surgery and that animal and imaging studies have proved it effective.
The FDA's demand for scientific evidence from clinical trials "is a valid position. But it is not the only position," Centeno told Nature. He says that it is sufficient to follow the guidelines of the International Cellular Medicine Society (ICMS), based in Salem, Oregon, an association of 1,100 physicians and patients that he co-founded and of which he is medical director.
Centeno and his supporters say that the FDA's request for an injunction is another blow for stem-cell clinics in their David-and-Goliath struggle with an industry-led alliance that wants to put a stranglehold on stem-cell therapies and restrict individuals' use of their own cells. In an open letter on 30 July, ICMS executive director David Audley accused the International Society for Stem Cell Research (ISSCR), based in Deerfield, Illinois, and including some 3,500 stem-cell researchers, of setting out to close their clinics. Motivated by the interests of a pharmaceutical industry unlikely to profit from the treatments, Audley says, the society wants to "change the laws in all civilized countries to outlaw these therapies". When questioned by Nature, however, Audley admitted he had no hard evidence for these assertions.
