Stem Cell Advocates and Critics Push Back on FDA Guidelines

Editor’s Note (9/22/2016): This article has been updated from the original to include the location of the hearing and a response from physicians involved in a stem cell treatment study.

Earlier this month the U.S. Food and Drug Administration opened its doors to public commentary on its newest guidelines on the use of therapies derived from human tissues, including stem cells.

The new guidelines, drafted last October, clarify existing regulations by outlining what uses of human tissue can be offered to patients without FDA approval. Many clinics offer patients unregulated, experimental procedures that have not yet undergone the official FDA approval process, which can take years. The major points in the new guidelines specify that: the function of these cells in the recipient’s body must be the same as in the donor; the treatment cells don’t affect the whole body of the recipient; and manufacturers can only manipulate the cells “minimally.” They also state which chemicals manufacturers can use to treat cells and prevent disease transmission.

The FDA notes the revised guidelines are meant to help manufacturers navigate regulations that are already in place. But many interpret them as a crackdown on clinics offering patients experimental procedures. “It is possible that after these public meetings the FDA may step up its activities on clinics to a more proportionate level and send a signal that it is indeed going to rein in the dangerous stem cell clinic industry for real,” says Paul Knoepfler, a professor of cell biology at the University of California, Davis, who specializes in stem cells.

Although preliminary evidence for stem cell therapy for a variety of conditions has been promising, its safety and efficacy are still unproved. There have been few clinical trials—they are expensive and take years. The result is that experts still don’t know important details like dosing and best clinical practices for stem cell treatments.