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 sparked it?
My sense is that a major trigger was Kimera Labs being linked some weeks back to an experimental infusion of exosomes into a COVID19 patient.
The letter is addressed to Kimera CEO Duncan Ross and Dr. Douglas Spiel, (each pictured in screenshots from one of several Kimera marketing videos highlighted by FDA). In my view the agency suggests that the firm’s exosome products are unapproved drugs.
From the letter:
“Kimera Labs markets exosome products to treat numerous diseases or conditions, including some that are serious or life-threatening. These products are administered by various routes of administration, including intravenously. Kimera Labs also supplies its products to health care providers such as Dr. Spiel, who is both a Clinical Consultant for Kimera Labs and President of Regenerative Solutions of New Jersey. Regenerative Solutions of New Jersey markets these products to mitigate, prevent, treat, or cure Coronavirus Disease 2019 (COVID-19).
You and your firm market your exosome products to treat diseases or conditions such as Parkinson’s disease, Multiple Sclerosis, brain injuries, diabetes, stroke, and spinal cord injuries.
…It appears that the above-referenced exosome products would be regulated as drugs…”
The agency includes numerous quotes from the YouTube videos about the Kimera exosomes, including this one attributed to Ross:
“I’ve noticed when we start treating Central Nervous System disease, spinal cord injuries, brain injuries, neurodegenerative problems like Parkinson’s, problems like MS we set the bar very very high . . . when we administer exosomes, I’ve seen some really remarkable things. I’ve been able and I’ve been privy to the benefits of seeing people who have been locked in wheelchairs and paraplegic starting to stand and walk. Seeing people that have been living their lives on drugs to maintain their blood pressure take the drugs away. People who walk on canes with Parkinson’s disease being able to throw the canes away and run and catch footballs.”
Yikes. People in wheelchairs getting up due to allogeneic exosome infusions? Parkinson’s patients throwing their canes away? Can the firm back that up with factual proof? Where’s the data? Update: The video cited by the FDA and from which I took the above screenshots has now disappeared from YouTube.
Based on the FDA letter and the videos identifying both Ross and Spiel as part of Kimera Labs (whose own website also mentions Spiel), to me at least there doesn’t seem to be much distance between these guys.
I have asked Ross for comment on the letter and if I hear back I will update this post.
It’s positive to see the FDA act so quickly on this given the concerns raised by the COVID-19 connection here that just surfaced weeks ago.
It seems clear more generally that the FDA is not going to sit by if unapproved and medically unproven exosomes are marketed for clinical use in people, including for COVID-19. As I’ve written before, one of the other unfortunate aspects to this kind of marketing is that exosomes have real clinical potential, but it needs to be proven in specific cases for specific exosome products with rigorous data before use in people.
In my view, to instead take a short cut by marketing unproven and non-FDA approved exosome-based therapies for clinical use and/or go ahead and inject them into patients is very dangerous and also risks damage to the germinal exosome field.