Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics […]
What are the current FDA Approved Cell and Gene Therapies? In the past many of us have wished there was a list of FDA-approved stem cell therapies. Patients and fellow scientists often asked me, but I couldn’t find a list. As a result, I made a comprehensive list of FDA Approved Cell and Gene Therapies,
List of FDA Approved Cell and Gene Therapies Read More »
During the week as I’m doing other stuff I keep my eyes open for interesting things to read, including over the weekend about stem cell research, COVID, CRISPR, and more for The Niche weekly recommended reads. This week a lot was going as we updated The Niche site to our new theme and format. I
Recommended reads: jobs, FDA letter, & The Niche new look Read More »
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
FDA OK’s more COVID-19 efforts of unproven stem cell clinics Read More »
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
Politics & FDA OK of 2 stem cell clinic COVID-19 efforts Read More »
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
Weekly reads: FDA news, goosebump stem cells, MSCs, autophagy Read More »
The FDA dropped a lengthy, extremely critical warning letter on a supplier of unproven exosome product called EUCYT Laboratories. For broader context, exosome therapy has somehow burst onto the scene when there’s no good data yet in my view to back up its use in the clinic. The FDA is taking notice with letters already sent
Getting 30 F grades? FDA Strongly Warns Exosome Firm EUCYT Read More »
It was fascinating to read a new JAMA piece by the FDA on unproven stem cell clinics and other regenerative medicine firms. Many of these guys are profiteering off of buzz about exciting, but mostly unproven technologies. While the JAMA opinion piece reiterates the agency’s commitment to evidence-based regenerative medicine, it also makes some other
Striking FDA Hahn & Marks JAMA pub on regenerative clinics Read More »
The FDA has stem cell clinics squarely on its radar screen now and it’s pulling the trigger with many letters going out to this problematic industry. In the past, sometimes years went by with no letters at all or one letter in total to stem cell clinics so this marks a major shift. Background on
Historic spring storm of FDA letters to stem cell clinic industry Read More »
A firm called Kimera labs just received an untitled letter from the FDA. The firm has been supplying non-FDA-approved exosomes to various customers including at least one stem cell clinic without sparking any obvious action from the agency, but on April 10th that changed with the letter, which in my view is quite serious. What
Kimera Labs FDA letter cites exosomes for COVID-19, more issues Read More »