September 22, 2020

The Niche

Knoepfler lab stem cell blog

American CryoStem

3 min read

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many troubling issues at the clinic. This warning letter just adds to difficult issues facing this clinic firm including a proposed class action patient lawsuit against it that that could get class …Read More

6 min read

FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some surprises. The title of the article is “Balancing Safety and Innovation for Cell-Based Regenerative Medicine,” which really gets to the heart of what I think the FDA is trying …Read More

4 min read

The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning letter and in an accompanying press release (PR) that ATCELL™ is not minimally manipulated and that its administration did not qualify as homologous use. For these reasons, the letter …Read More

4 min read

Is the largest affiliated group of stem cell clinics in America, Cell Surgical Network, now using laboratory-proliferated stem cells in patients? Do they already have some kind of final FDA approval for this clinical approach given that lab-grown stem cells are generally viewed as drugs requiring premarket approval? Over the years I’ve reached out to interview many members of our diverse community in the stem cell arena including those operating stem cell clinics. One past such past interview (here and here) was with the …Read More