Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. While the FDA didn’t send R3 Stem Cell a formal warning letter, in my view the agency made it very clear in the “untitled” letter that this firm should make some changes. The letter went out both to R3 Stem Cell and its dozens of …Read More
Does it make any sense scientifically or medically to use stem cells for pain? I’m skeptical in most cases today. The whole idea of stem cells for pain has been on my mind for a number of reasons. For one thing, more stem cell clinics are marketing unproven stem cell therapies at a high price specifically for pain relief lately. People are even having conferences on this concept. See the email ad I got yesterday on one such conference below Is there any FDA-approved stem …Read More
Today was the first part of the FDA’s 2-day meeting on stem cell draft guidances. It was a great meeting I thought. A few consistent themes and notable things emerged as raised by participants.
The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees? Who is likely to say what? If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have a satirical cartoon from some time ago I drew imagining such a future.