August 8, 2020

The Niche

Knoepfler lab stem cell blog

RMAT

5 min read

Every year in December and early January I do a post predicting some key events for the stem cell and regenerative medicine field for the upcoming year and today’s post contains my predictions for 2020. You can see my past 2019 predictions along with my grades for them here. I gave myself a B+ for 2019. What grade will I get for 2020? I don’t yet of course, but I often can’t resist making positive predictions even if they are relatively high risk in …Read More

2 min read

This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm names are to relevant press releases or other reference material. A special thanks to some folks at ARM for helping me keep the list up to date. You can …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

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