December 1, 2020

The Niche

Knoepfler lab stem cell blog

FDA COVID-19

4 min read

In my view, it seems likely that the FDA has opened a big can of worms by starting to clear the COVID-19 trials and programs of for-profit stem cell clinics and other related firms. OK to Stemedica trial The FDA just approved another such effort, this one by the firm Stemedica. You can read more about previous such COVID-19 cell therapy clearances for the unproven clinic firms Celltex and GioStar here. The Stemedica trial is similar to some of the other cell therapy efforts for …Read More

6 min read

The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of cell therapy trials for COVID-19 mostly without much data, but the clearance of a few programs by for-profit stem cell clinics is especially problematic in my view. FDA on …Read More