August 4, 2020

The Niche

Knoepfler lab stem cell blog

CBER Peter Marks

5 min read

In a nutshell, what does all of this week’s big FDA developments on stem cells and regenerative medicine mean for stem cell clinics? There’s much to be upbeat about so overall I’d say it’s good news, but I see three significant potential problems too. Dang. The good news is that the FDA seems determined to deal with the highest risk stem cell clinics, but unfortunately the FDA sent mixed messages on clinics in a broader sense and in some ways left the door open …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