July 11, 2020

The Niche

Knoepfler lab stem cell blog

FDA needs to act boldly on unproven exosome therapies

Exosomes visualized by EM: Credit IBM Research
Exosomes visualized by EM: Photo Credit IBM Research, labeled as available for reuse.

The FDA needs to do more about clinics and suppliers of unproven “exosome therapies.”

Dubious exosomes are sadly just the newest gimmick for some firms in the stem cell/regenerative medicine clinic arena right now. They are available at many stem cell and other clinics right now, but who knows what’s in the syringe? Also, people have been hurt in Nebraska by some product involving exosomes.

There is legit, exciting exosome research ongoing all over now. I believe these little cellular bubbles full of different molecules could have real promise in some ways clinically in the long run. But that has to be proven and it hasn’t been so far. Yet, we’re seeing an increasing number of clinics and suppliers pitching questionable exosomes for all kinds of things including aging. The suppliers are hawking exosomes right now both to patients but more so to doctors and chiropractors.

I’ve seen a few such firms now suggesting that exosomes may help with the COVID-19 disease from the coronavirus, without evidence of safety or efficacy. I hope they don’t start selling this idea literally.

Clinics and suppliers are selling exosomes for just about anything these days.

Just last week I wrote about Liveyon selling a new exosome product to supposedly fight aging and maybe other maladies too, but I’m so clear on that. It seems to be a cosmetic product, whereas other exosome firms are mostly focused on injecting exosomes into the bloodstream or specific tissues.

How did we get here?

From 2016-2019 the FDA wasn’t very clear about exosomes even as we saw people hyping them, but now the agency has become much more concrete about this.

The message is that exosomes are generally drugs requiring premarket approval. In other words, it is probably often illegal to market exosomes for use in patients or to use them in the patients. This is not just a matter of legal technicalities either given again that patients who injected with unproven exosomes have ended up in the hospital.

Some of the manufacturers are playing coy by trying to distance themselves from their clinic customers that are injecting their exosomes into patients, but in my view certain manufacturers probably know that their product (not approved for human use) is nonetheless being used clinically. They keep selling it to clinics anyway for the profits.

Regarding those patient harms in Nebraska, the FDA also mentioned related to that event that exosomes are generally going to be drugs. In an exosome safety advisory the agency said (emphasis mine):

“There are currently no FDA-approved exosome products. Certain clinics across the country, including some that manufacture or market violative “stem cell” products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions. They may claim that these products do not fall under the regulatory provisions for drugs and biological products – that is simply untrue. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements.”

Also, in a recent untitled, sternly-worded letter to Chara Biologics, an FDA footnote (see screenshot below) had literally the same general, unambiguous cautionary note about exosomes being drugs.

Exosomes are drugs per the FDA
Exosomes are drugs per the FDA; screenshot of part of an untitled letter to Chara Bio.

This seems clear cut, right?

Yet, it’s an odd situation now where the FDA is sending untitled letters (not even official warning letters) to companies that it says seem to be marketing unapproved exosome (and stem cell) drug products for clinical use.

Puzzlingly, officials have so far been unwilling to say more about what happened in Nebraska with the patients who were sickened there by some kind of dubious exosomes.

Why the secrecy? The public doesn’t even know who the manufacturer of those exosomes was and the name of the clinic that injected them. Is the hush-hush mentality because of a serious ongoing investigation?

The FDA needs to be bolder on exosome manufacturers, suppliers, and clinics right now. I hope wheels are turning behind the scenes to yield concrete action soon. Many people are at risk. The legit exosome field is also being threatened.

%d bloggers like this: