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 to others including an untitled letter to Kimera Labs and on the same date another to a physician who used Kimera products and was at one time amongst Kimera leadership, Doug Spiel. There was also some indication that Spiel may have been involved in the process of a COVID-19 patient getting infused with exosomes without an OK from the FDA.
The letter to EUCYT is one of the more lengthy warnings that I’ve seen recently. It highlights 13 major observations. Remarkably, the letter uses forms of the words fail or failure, 30 times.
In a way overall I see the letter as an F grade for EUCYT on what it is doing. The observations include many deviations from standard clinical lab practices.
In addition, the FDA notes the firm is apparently marketing unapproved exosome drug products. For instance, the agency mentions that the products fail to meet the homologous use and minimal manipulation criteria.
Sadly, EUCYT also began marketing products for COVID-19, which seems to me to be especially egregious. From the letter:
“Most recently, you began marketing an exosome product, COVIXO, for the treatment or prevention of patients’ Coronavirus Disease 2019 (COVID-19). Your https://eucyt.com/products/covixo/ website states “COVIXO drives cellular functionality including augmenting the type 1 interferon pathway . . . that is important for anti-SARS-CoV-2 activity” and “[t]he unique mechanism of action for COVIXO enables each patient to generate their own adaptive immune response against SARS-CoV-2, including memory T cells and antibodies, which will further protect each patient from subsequent exposures and infections.”
The firm has a YouTube video claiming they can do something for COVID-19 as well. See below.
The warning letter is addressed to EUCYT CEO Travis Bird.
Based on a tip, I wrote to Mr. Bird on March 1 asking him if his firm was the supplier that was involved in the exosome product harm to patients in Nebraska, but never heard back. While the warning letter doesn’t directly mention the Nebraska situation it does tie the firm to it:
“With regard to your unapproved exosome product XOsomes™, we direct your attention to FDA’s Public Safety Notification on Exosome Products, available at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products. FDA issued that public safety notification following multiple reports of serious adverse events experienced by patients who were treated with XOsomes™.”
Just to clarify, the FDA notice mentioned here in the warning to EUCYT was about the patients being harmed in Nebraska with unproven exosomes and now the FDA links these bad outcomes to the same firm in the warning letter by saying, at least as I read it, that it was this company’s product XOsomes that caused the adverse events in Nebraska.
Overall, it’s crystal clear that exosomes are generally drug products requiring pre-approval from the FDA prior to use in patients. And the agency is willing to take relatively quick action against non-compliant exosome firms.
If you truly believe specific exosome products can be helpful for specific conditions, get your own relevant data and work with the FDA, before you or anyone else injects your product into patients, who might get seriously hurt.