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 previous such COVID-19 cell therapy clearances for the unproven clinic firms Celltex and GioStar here. The Stemedica trial is similar to some of the other cell therapy efforts for …Read More
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When you sit down to read science on the weekends lately, assuming you are not primarily a COVID-19 researcher, how much COVID stuff seeps into your reading? As I was going over some of this year’s recommended weekly reads posts here on The Niche, I’ve realized that an increasing amount of COVID-19 research has joined the list. Part of this is because of the explosion of cell therapy work and news on COVID, but also I’m just interested in the science of COVID. Before …Read More
What’s been going on in the stem cell and regenerative medicine field over the past week and what are some worthwhile things to read? Today’s post has recommended recent reads from the scientific literature and the media. I’ve also got our weekly stem cell/regenerative medicine quiz question and the answer to last week’s. You can check out last week’s recommended reads here, which has last week’s quiz question. Toward the bottom of the post there’s also a “blast from the past” link to a piece …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 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
Graft-versus-host disease (GVHD) is counterintuitive In the weeks and months following a transplant, a major concern is the recipient’s immune system rejecting the “foreign” biological material. But in GVHD, the opposite happens: transplanted tissue unleashes a horde of T cells that spark a cascade of inflammation, within 100 days. Typically, GVHD follows a bone marrow transplant (BMT). Eighty Percent Mortality BMT has been used for more than half a century to treat and possibly cure certain cancers and single-gene conditions like sickle cell disease, …Read More
Today’s post is the latest edition of my weekly recommended reads, which this week include Fate Therapeutics, COVID-19 updates, AAMC, and more including some great pubs such as one on 2 modes of PRC2 function. Also check out this handy resource: Helpful 2020 List of Stem Cell Journals and this blast from the past post of 10 years ago: Keep Your Stem Cells Away From BPA. I’ll start with the mid-August 2020 recommended pubs and then go to the media items, but first I wanted to …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 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
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
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
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