June 2, 2020

The Niche

Knoepfler lab stem cell blog

FDA Commissioner Scott Gottlieb

5 min read

When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman. Berman and his clinic partner, urologist Elliot Lander, run an adipose stem cell firm called California Stem Cell Treatment Center. This clinic seems effectively to also be the HQ …Read More

4 min read

We need more investigations of for-profit stem cell clinics selling what some view as ‘snake oil.’ Over the years I’ve mainly resisted using terms like “snake oil,” but that phrase is being used more often and more recently I think we need to be blunt about what is being sold. Part of effectively countering the worst of the clinics is for the media and others to do probing investigations. We need to shine some major sunlight on their practices, which then helps inform both …Read More

4 min read

Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months ago. Some of the cases of lost vision reportedly were documented by independent physicians including Dr. Thomas Albini. In 2017, the FDA issued a warning letter to USRM’s business U.S. Stem …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

How far will stem cell clinics go to market their non-FDA approved “treatments” that they often claim will have miraculous results? I’ve never seen anything quite as striking as what some clinics in the Seattle area are now doing. In the past, we’ve seen clinics take researchers’ pictures, quotes, or videos to use for their own marketing. In the last 1-2 years we’ve seen increasing numbers of mainstream media ads for clinics too (see here and here, for example) so the clinics are thinking …Read More