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.
You’ve been working for years to get tighter regulation of clinics that offer unlicensed stem cell therapies. How important is this week’s action by the FDA?
I don’t think we know the scope of it yet and if it’s going to be epic change or something more in the middle, but it’s still a big deal. For one, the statement from new FDA Commissioner Scott Gottlieb is very direct and clear. He’s saying this is important to the FDA and we’re going to do something about it. And the fact that his words are combined with news of enforcement in Florida and California emphasizes it’s not just talk; the FDA is backing this up with action.
stem cells are the present and future.
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