The US Food and Drug Administration has embarked upon a legal battle to extend its authority over stem cell treatments. It has enjoined a Colorado company, Regenerative Sciences, from treating patients with stem cells from their own bone marrow or synovial fluid. These are being injected to treat fractures, torn tendons and other ailments. The clinic charges patients US$7,000–9,000 and does about 20 procedures every month.

Christopher Centeno, the medical director of the company, is ready for a fight. He disputes the FDA’s jurisdiction. Since the company uses a patient’s own cells, as IVF clinics do, it is none of the FDA’s business.

Both sides realise that the case could be a landmark decision. Conventional stem cell researchers are wary of shady operators who claim therapeutic benefits for stem cells without much research. Douglas Sipp, of the International Society for Stem Cell Research, worries about what will happen if Centeno’s company wins in the courts. "Companies would likely feel empowered to ignore requirements for demonstrable safety and efficacy of autologous medicinal products, creating an 'anything goes' atmosphere," he told Nature.

And Centeno agrees: "If we win, the entire regulatory structure for autologous cell processing, with or without culture, will be rewritten such that any physician using good practices and treating patients responsibly can use stem cells as part of his or her medical practice," he says. ~ Nature, Aug 17