FDA

FDA OK’s more COVID-19 efforts of unproven stem cell clinics

The-FDAs-big-COVID-stem-cell-clinic-can-of-worms-small

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

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Weekly reads: FDA news, goosebump stem cells, MSCs, autophagy

Levy-et-al-MSCs-Science-Advances

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

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Getting 30 F grades? FDA Strongly Warns Exosome Firm EUCYT

EUCYT-CEO-Travis-Bird

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

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Striking FDA Hahn & Marks JAMA pub on regenerative clinics

Dr-Stephen-Hahn-Commissioner-of-FDA

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

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Historic spring storm of FDA letters to stem cell clinic industry

FDA-letter-stem-cells

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

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Kimera Labs FDA letter cites exosomes for COVID-19, more issues

Duncan-Ross

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

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FDA needs to act boldly on unproven exosome therapies

exosomes-visualized-by-EM

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

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In landmark step, judge does not defer to FDA in stem cell clinic chain case, orders full trial

Judge-Jesus-Bernal

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

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