January 16, 2021

The Niche

Trusted stem cell blog & resources

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

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

3 min read

Should we call it stem cell synchronicity for stem cell supplier firm Invitrx? What was it about March 16? Sometimes strange things happen in the stem cell world such as last week on March 16 I wrote that the FDA needs to do more about unproven exosomes, and then on the same day a new FDA warning letter went out to Invitrx mentioning almost as an aside an unapproved exosome product amongst many other products and issues. No, I don’t have some secret red telephone where I …Read More

3 min read

The FDA needs to do more about clinics and suppliers of unproven “exosome therapies.” Dubious exosomes are sadly just the newest gimmick for some firms in the stem cell/regenerative medicine clinic arena right now. They are available at many stem cell and other clinics right now, but who knows what’s in the syringe? Also, people have been hurt in Nebraska by some product involving exosomes. There is legit, exciting exosome research ongoing all over now. I believe these little cellular bubbles full of different …Read More