Exosome Products Remain Unapproved Drugs: Kimera Labs
It’s no secret to anyone watching the FDA regulatory space in orthobiologics that exosomes require full FDA approval with clinical trials. However, no exosome product being sold today has that type of biologic drug approval. Despite a steady diet of FDA letters to the offending companies, one of the last shoes left to drop has been Kimera Labs. However, an FDA Warning Letter sent in September 2023 and just released, now makes Kimera’s regulatory status clear. Let’s dig in.
What are Exosomes and How Does the FDA Regulate Them?
Exosomes are the communication vehicles between cells. They come in two types of commercial products. One is just centrifuged amniotic fluid and the other is the media in which cells grow which is also then centrifuged. Despite very limited data that any of these commercial products help anybody, they have been hyped and sold widely.
The FDA has taken a very firm stance on this issue by putting out a blanket warning to these companies in 2020. That statement made clear that if you are selling anything you call exosomes, you need to get full FDA drug approval for each product and clinical indication. Since a slew of companies continued to sell these products without this type of approval, the FDA has sent several letters out:
Those letters make clear that exosomes are unapproved drug products.
I’ve blogged a number of times on Kimera (see blog 1, blog 2, blog 3). Kimera is a company in South Florida that has been growing mesenchymal stem cells in culture. They then bottle the media the cells were grown in after concentrating the exosomes via centrifugation. The company sold exosomes as a cosmetics line but also had representatives market at physician conferences that this product could be used for musculoskeletal and other uses. In fact, Kimera has had sales reps (one that it later disowned) who have actively hawked its exosome product to me for various orthopedic and neurologic uses. I have also visited their booths selling to physicians at medical conferences.
Kimera Labs Untitled Letter
In 2020, Kimera Labs was sent an untitled letter by the FDA regarding its use of exosome products. That letter stated that the company’s exosome products were drugs based on the advertising and promotion performed by Doug Spiel, M.D. a clinical consultant for the company. Dr. Spiel had many lectures on YouTube promoting exosomes for many clinical problems. As of this writing, several can still be found on that website.
Kimera Lab’s Warning Letter
Kimera hasn’t been on my radar for a while. Part of that was simply that the exosome sales space had gotten so out of control that this company became lost in the daily exosome sales pitches scattered all over Facebook. However, that changed when a colleague sent me a September 2023 Kimera Labs 2023 FDA Warning Letter. This was just posted online on January 4th, 2024.
It looks like the company dealt with on-site FDA inspections for the better part of 2022. In the letter, the agency stated that their exosome and amniotic fluid products were unapproved drug products. That’s interesting, as Duncan Ross, Ph.D. their CEO had previously stated on Linkedin that the company has never had any regulatory issues with the FDA and even provided what appeared to be a clean 483 inspection report as proof.
Of note, the recent FDA inspection found numerous cGMP violations that included:
- Inadequate SOPs to validate sterility. The company, according to FDA, failed to validate that its products were sterile.
- Inadequate SOPs for environmental monitoring that allowed for too many CFU hits on plate testing. According to FDA, this could present a sterility safety issue.
- Failure of the company to always maintain written records of sterility breaches.
- Failure to test each batch of amniotic fluid for sterility.
- Failure to ensure that all of its products have uniform potency and strength.
- Failure to ensure that the penicillin that is used in the culture media isn’t making its way into the exosome products.
- Failure to validate cleaning protocols in the lab.
- Using research-grade components in products that are injected into humans.
- Failure to establish via experimental testing the accurate expiration date for its exosome products.
Kimera Continued to Sell Exosome Products After It’s Untitled Letter
In the 2023 FDA Letter, it was noted by investigators that Kimera continued to sell exosome products after its 2020 letter. Kimera’s position at the time was that its products were purely for cosmetic uses. Despite this assertion, the FDA considered the company’s products unapproved drugs.
In addition, the recent Warning letter states that while the company would cease making amniotic fluid and exosome products, it wanted to continue to sell out its current inventory. In response, the FDA wrote:
“Your continued distribution of your products violates the FD&C Act and PHS Act.”
The company has 15 days to address these issues and respond. None of that will allow the company to sell exosome or amniotic products right now.
This Warning Letter Came AFTER an IND Was Granted
The myth spread by many sales reps selling exosomes has been that if the company has an FDA IND and permission to perform a clinical trial on a specific disease, that company can sell its exosome products to the public. That contention is, of course, fiction but the Kimera case is illustrative. According to a company press release on May 16th, 2023, Kimera was granted an IND to study its exosome product on COVID-19 patients. The FDA Warning Letter came after that permission was granted.
The upshot? IMHO this FDA Warning letter has been a long time coming for Kimera. IMHO the company has played fast and loose with aggressive marketing to physicians of its exosome products for all sorts of indications. It will be interesting to see Kimera’s next move.