October 29, 2020

The Niche

Knoepfler lab stem cell blog

FDA

5 min read

The FTC has sharply increased its oversight activities against stem cell and regenerative clinic firms. These new actions include quite a few warning letters. Here is the FTC database for COVID-19-related warning letters. Note that recently the FTC added a new, helpful option to view all of its warning letters here. It’s a good source of information. FTC warns many stem cell & related firms From USA Today, Brent Schrotenboer had this recent piece Stem cell companies sell hope with unproven medicine for COVID-19. Some …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

4 min read

What science and stem cell pubs are you reading right now and what do you hope to get too soon? Sometimes science means getting out in the field. Now there are no wild stem cells out there roaming the fields to catch and analyze, but there are other ways. A couple of my kids and I went out to watch the Perseid Meteor Shower a few weeks back. We brought our camera with us to try to catch some meteors with leaving the shutter …Read More

5 min read

Ready for the latest recommended weekly reads in the world of stem cells and the regenerative medicine space including a bunch of important new FDA posts & changes? This post has quite a lot on the FDA since it had a very big week with several new items of major importance to the cellular and regenerative medicine arena. I’ve linked to each announcement below with the agency’s title of the announcements. Underneath I provide some analysis and ask questions. I’ve also included some other stem …Read More