When I first saw the new FDA warning on stem cells for pets and the logo for the company that received it, I was surprised in a few ways. I don’t recall ever seeing such a letter and the logo is something else.
We’ll get into all of that in a moment, but first, since I recently did a look at stem cells on Reddit, I thought about what science-related stuff it covers. Seeing a gap with chromatin, I’m trying to get a research community going on Reddit related to chromatin, epigenetics, and epigenomics. If anyone is interested, please check it out and join the chromatin subreddit.
Unusual FDA warning on stem cells for pets.
Here’s the FDA warning letter to Safari Stem Cell, LLC. Why was I puzzled on this one? I know the FDA regulates veterinary regenerative medicine too, but with perhaps 2,000 unproven stem cell clinics injecting people and just a fraction of them ever subject to any kind of FDA action, I would think CBER would make it a priority to take care of the human clinic situation.
Just for background, I’ve had pets most of my life so I’m not downplaying the importance of getting regenerative medicine for pets right, but the situation with human stem cell clinics is just awful. Note that UC Davis has an exciting veterinary regenerative medicine program so I’m well aware of its potential.
The warning is similar in some key ways to FDA letters to clinics that inject people with stem cells. As is typical, the letter notes the products are unapproved drugs and there are CGMP concerns.
MedPage Today also covered the Safari Stem Cell warning. From that article, there is some info from the company:
“Steven Garner, the president of Safari Stem Cell, told MedPage Today that the company has already made efforts to address the agency’s concerns, including building a new CGMP compliant lab and updating the company’s standard operating procedures and protocols.
“We were expecting most of the allegations and have addressed them,” Garner said in an email. “We have been in operation for over 10 years with no notice from the FDA. We do have significant differences of opinion but are working with consultants on how to move forward.”
If they were expecting the allegations from the FDA, did Safari Stem Cell start the process of becoming compliant before getting the letter? I hope so. The part on “significant differences of opinion” is interesting too and rings a bell with some human clinics’ responses when they get warnings. Maybe that’s why the logo says, “Get Over it! Stem Cells Work!” Does this clinic have data to back that provocative statement?
More recommended stem cell reads
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- Source: https://ipscell.com/2024/06/recommended-reads-fda-warning-on-stem-cells-for-pets-chromatin-aging-hscs/