July 12, 2020

The Niche

Knoepfler lab stem cell blog

FDA Commissioner Scott Gottlieb

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

3 min read

The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already took some action too on clinics in Florida and in California. So today we heard about both a bold statement of vision on how the FDA will deal with …Read More

3 min read

Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The company’s penny stock $USRM has been gyrating for months and I had earlier wondered if could be some fake news about it. The USRM news now seems real and not …Read More