One of the most contentious areas in the regenerative medicine arena is whether a fat tissue product called stromal vascular fraction or SVF is a drug. The FDA says SVF, even in autologous form, is a drug. It is seeking an injunction against a California-based network of SVF clinics but lost the initial case. That is now pending an appeal, which could be decided any day now.
The 9th Circuit Court of Appeals has not yet released its ruling on the case, which again hinges on whether autologous SVF is a drug. It’s been more than three months. The FDA prevailed in another SVF case in Florida.
Interestingly, the FDA just issued a new warning letter but for allogeneic SVF. Let’s start by discussing that letter.
FDA Warning letter on allogeneic SVF
Here’s the FDA warning letter to Akan Biosciences.
While the allogeneic SVF focus makes this unusual, on the other hand, the warning to Akan Biosciences is typical for such letters in that it notes that the product being marketed is an unapproved drug and highlights several GMP-type problems. Those two general types of points dominate many FDA warning letters in the cell therapy space.
As I’ve wondered in the past when such letters pop up, why this firm?
There are hundreds of non-compliant clinics and manufacturers marketing unapproved cellular drugs. Maybe in this case it was the unusual allogeneic SVF product that sparked attention? If the FDA does devote precious time and resources based on perceived risk, are they doing anything about supportive oligonucleotide therapy or SOT? I see it as presenting serious potential risks as it is sold at dozens of US clinics.
More recommended reads
Aspen wins $8M to advance Parkinson’s stem cell therapy, Parkinson’s News Today. Good news. I wrote recently about how Aspen Neurosciences had also recently dosed its first patient in its new trial and other good news.
Despite Setback, Neuralink’s First Brain-Implant Patient Stays Upbeat, NYT. The implant in Neuralink’s first participant has had problems including loss of connectivity to the brain.
Fort Lauderdale woman says she paid over $14K for ‘stem cell injections’ that did not cure arthritis, 7 News Miami. This has a few interesting elements to it but the part about the FDA suggesting patients turn to state rather than federal (i.e., the FDA) officials to deal with stem cell clinic problems is concerning. Many clinics are apparently violating FDA regs and so potentially federal law.
‘CSI: Vegas’ Ends Its Series Run With a Shocking, Unexpected Villain Twist, Variety. I liked the original CSI but haven’t been into the spinoffs as much. I do think it is hilarious how the CSI: Vegas series finale has this somewhat savage quote on stem cell anti-aging baloney:
“With Max (Paula Newsome) kidnapped and Chris (Jay Lee) injured by some sort of nerve agent and in the hospital, the “CSI” team continues to place the blame on tech billionaire Truman Thomas (Owain Yeoman) — until they find his dead body. (Says one character, who discovers Thomas had been injecting himself with de-aging synthetic stem cells: “If he wanted to live forever, my guy should have worn a bullet-proof vest.” LOL, truth! Those crazy tech billionaires, amirite?)”
So far, there is no evidence that stem cells, synthetic or not, can do any de-aging tricks. They can’t stop bullets either.