Paul Knoepfler, a stem cell researcher at the University of California, Davis and author of The Niche blog, has warned for years about the proliferation of unlicensed stem cell clinics and the danger they pose to both patients and legitimate stem cell research. He was pleased this week to see the FDA announce a crackdown — and then back up that rhetoric with action. The FDA sent a stern warning letter to a Florida clinic that left three women legally blind after an unapproved treatment. And federal marshals raided a California clinic and seized dangerous therapies, made in part from smallpox vaccine.
But while he welcomed the actions, Knoepfler cautioned that it’s still unclear how aggressively the FDA will move against the hundreds of unlicensed clinics peddling dubious remedies. STAT spoke to him about what it would take to truly clean up the industry. The conversation has been lightly edited for clarity.