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 »
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 …
‘Captain Kirk’ regenerative clinic supplier Invitrx gets long FDA warning letter Read More »
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 …
FDA needs to act boldly on unproven exosome therapies Read More »
In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgement against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a …
Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. FDA and R3 Stem Cell While the FDA didn’t send R3 Stem Cell a formal warning …
US Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1. I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways. To me Comella seemed like the driving force behind the company, which is now subject to …
Kristin Comella resigns from embattled clinic firm US Stem Cell Read More »