October 19, 2020

The Niche

Knoepfler lab stem cell blog

FDA

3 min read

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 to others including an untitled letter to Kimera Labs  and on the same date another to a physician who used Kimera products and was at one time amongst Kimera leadership, Doug …Read More

5 min read

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 key points, some of which are newer and worth digging into on a deeper level. What’s new here from the FDA? The piece by CBER Director Dr. Peter Marks …Read More

5 min read

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 lead-up to wave of FDA activity I count 7 letters in a less than two-month span from mid-March to now, which may be the most in history in the …Read More

3 min read

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 sparked it? My sense is that a major trigger was Kimera Labs being linked some weeks back to an experimental infusion of exosomes into a COVID19 patient. The letter …Read More