A study published earlier this year in Cell Stem Cell indicated that at least 351 companies in the United States are marketing unapproved stem cell procedures at 570 clinics across the country. In response, the FDA is now waging a nationwide crackdown on stem cell clinics that has some scientists concerned that doing so could hinder research progress in this treatment area.
The FDA has not regulated stem cell therapy, but concerns have increased after procedures at unregulated clinics have left some patients blind or caused others to develop tumors. The FDA proposed regulating cells as they do drugs, meaning clinics would have to go through a costly and rigorous approval process before treating patients.
Those opposed to the FDA regulation are concerned that it might hinder innovation in the area of stem cell transplants, saying that it comes at a time when leading stem cell researchers are excited about new studies showing that the cells appear to be safe and effective in treating a variety of diseases.
Those in favor of new restrictions on these clinics worry that, if the FDA does not act, more patients will seek unregulated care at these for-profit clinics that may not have the expertise to properly prepare and administer stem cell treatments.
Sources: Turner L, Knoepfler P. Selling stem cells in the USA: assessing the direct-to-consumer industry. Cell Stem Cell. 2016;S1934-5909:30157-6; Stat News, September 9, 2016.