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.”
Yikes.
The firm has a YouTube video claiming they can do something for COVID-19 as well. See below.
https://youtu.be/Lvem76Wr3pI
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.
The letter seems to show that the way Eucyt was producing their “therapies” (which in fact are not since it has no proven effect, hence cannot be considered as a “drug”) is an insult to the industry as well as to science. There is a deep concern on how long the exchange of letters, documents and reviews between the FDA and Eucyst will go on: when FDA will kegally stop Eucyst selling snake oil? What are the legal provisions? Can anyone inform me of the subsequent procedure and how long this may last?
Not sure why I have to educate the market and run a GMP lab, with all the costs associated with that, while avoiding adverse events, and then be linked to something like this, which impacted me financially. Why exactly did my name and brand need to be mentioned here? Reeks of paid subterfuge.
I will take my solace in the IND’s and hopefully approved BLA’s.
You are aware that I burn through the value of your grants in 1 to 2 months ?
@Duncan,
Why do you say “name and brand”? Kimera was mentioned in the post, but not you personally, right?
By “paid subterfuge” what do you mean and how would that make any sense?
Where do your IND applications stand?
Try to imagine the stress I have had over the moving bar that is COVID. First, HCQ would impede the functionality of our product, now remdesivir and dexamethasone are also standard of care. How do you lock down a treatment protocol like that? The major universities who were interested in trials now don’t have the staff, they’re exhausted. Then Doug instigated an FDA letter, forcing me to distance myself from a really brilliant physician. I was inspected by the FDA and didn’t receive a warning letter. He got me one without even trying. My competitors use magnetic beads to isolate exosomes for human use while others simply lie about what they make. It’s exhausting. We are now submitting an outpatient protocol. I believe we have it now. I may even process the cytokine assays myself on a Siemens immulite 1000, potentially exposing myself. You are so specific towards us, you sound like Centeno..who I’m actually starting to understand, however, I still don’t think it’s fair towards our company. My employees have families and the FDA, as well as the rest of society, didn’t know what an exosome was until I expended significant amounts of capital. I may not have been Pfizer when we began but we are now.
There is no question that this country is “FUBAR” in regard to our politics, our public health, our FDA, CDC, our medical boards, the AMA, the AOA, the chiropractic state boards, the Naturopathic boards, etc. etc.
The problems in the stem cell world goes right back to the FDA in my opinion. Their definition of what a drug is and then calling stem cells a drug has gotten us into this mess. The “stem cell companies” that have sprung up over the last 5 years or so saw an opportunity and seized it. They decided that they did not want to break the law by growing stem cells in a lab the correct way since then the FDA could say they were selling unapproved drugs. So instead they decided to follow the FDA’s guidelines and make stem cells with “little or no manipulation” and proceeded to buy whole umbilical cords from different sources and then simply took these cords and mechanically separated the material and took the mixture of tissues and cells and placed these into the small 2 ml vials that are then frozen and sold to the unsuspecting doctors who believe everything that these company’s sales people tell them and provide fake documents that support their claims. Many bad reactions have occurred with these since these vials contain incompatible tissues from the mother and from HLA and ABO white blood cells since her tissues are part of the cord,
If the FDA would change and say that only pure stem cells could be used and sold to the doctors then all of these problems would go away. That solution would be great for the public and would help millions of people but those companies who have spent millions trying to get their stem cells approved by the FDA by way of standard clinical trials would be very upset but if we all put out thinking caps on we should as an industry solve these problems. But maybe the FDA’s nasty letters are going to change all of these problems but that means that people are not going to get the treatments they are wanting and will not for years since after all of these years we still have no FDA approved pure stem cells for any condition on the market.
Reading through the FDA letter is just plain scary. Any qualified science personnel should know that the majority of those issues never should have occurred. And if the company is even trying to be legitimate the other issues shouldn’t have been as atrocious as they were. No aseptic protocols. No validations. Umbilical cords processed on cutting boards that get washed at the eyewash station!? One wonders if the cutting boards are even autoclaved after ‘cleaning’. Do they even know how aseptic techinique and processing works?
Once a facility reaches that level of citation its interesting that it doesn’t just get shut down. Regardless of if any these products have any medical use as is (probably not, but no data in any case) you have to process cellular therapy with a certain amount of standards in place. A good place to start would be AABB or FACT… even if just for reference. Then review qualified ISO certification and make sure you have a biologics production specialist to do it right.
Agreed. Some of the things mentioned are just mind boggling.