September 26, 2020

The Niche

Knoepfler lab stem cell blog

Scott Gottlieb

5 min read

Friday and Saturday showed a burst in FDA activity related to unproven stem cells and regenerative products including a warning letter to the unproven perinatal “stem cell” provider Liveyon. This was an unusual 48-hour period and a very good one for those who believe in science-based regenerative medicine but in my view a bad day for perinatal stem cell clinic and exosome suppliers. For general background on exosomes see these past The Niche posts. I’m sure there are a lot of hardworking folks at …Read More

4 min read

Today the United States District Court of the Southern District of Florida entered a permanent injunction against stem cell clinic firm US Stem Cell and co-defendants including U.S. Stem Cell Clinic. Patients have been harmed by the unproven treatments sold by these firms. US Stem had lost the case a couple weeks back, but now we know the details of the permanent injunction on them by Judge Ursula Ungaro. The order against US Stem, which is likely to be appealed, is appropriately strict in …Read More

2 min read

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the warning letter is the clarity it brings that, yes, allogeneic umbilical cord stem cell and other perinatal stem cell products generally are drugs requiring a cleared IND and a …Read More

3 min read

Maybe the announcement that Commissioner Scott Gottlieb will be leaving the FDA soon shouldn’t have caught us all off-guard, but it did. Gottlieb isn’t a perfect Commissioner, but he brought a sensible, open approach to running the FDA that was very refreshing. Amongst all the top leadership in the Trump administration, Scott Gottlieb stood out as being particularly supportive of his agency and its core mission. If anything he was the anti-politician in the room. Is that what did him in? It’d be helpful …Read More