November 27, 2020

The Niche

Knoepfler lab stem cell blog

Adam Feuerstein

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

1 min read

There has been a lot of excitement this week about a press release from stem cell biotech Athersys that reported that treatment of stroke patients with its product MultiStem was associated with a statistically significant improvement at 1-year. This sounds encouraging and the stock has spiked up as a result. However, there are some naysayers including long-time stem cell biotech critic Adam Feuerstein, who today painted the Athersys press release as little more than spin. Feuerstein went through a list of what he describes …Read More

4 min read

Osiris, a cellular therapy biotech, recently received a so-called “untitled letter” from the FDA. The text of the letter seems on the whole negative in my opinion, while the company’s public reaction to the letter on the other hand could be seen paradoxically as rather cheery. What’s going on here? With Halloween coming, one has to wonder if the FDA letter to Osiris was more like a trick or a treat. My take is that it sure doesn’t seem like a Snickers bar. The …Read More