I’ve just returned from our licensed Cayman Island advanced-practice site, where we can culture expand to get many more stem cells. At the Cayman site, it’s likely that trillions or hundreds of trillions of exosomes are produced each month by the cells in culture. However, we throw them all away. Why? Let’s explore that and in the process learn something about the bizarre exosome trend sweeping the nation.
My Regen Med Street Cred
Outside of Philippe Hernigou, I’ve published the most research on the use of stem cells to treat orthopedic injuries. In addition, I can also claim to be the first person on earth to perform many of these procedures. In that time, through the culture of stem cells to grow more, I’ve likely overseen the creation of a quadrillion or more exosomes. However, I threw them all out and will continue to do just that. Why?
What Is an Exosome?
Exosomes are tiny little packets excreted by stem cells with messages and other goodies for the nearby cells. In fact, just about all cells excrete exosomes to communicate with other cells in their environment. The idea behind this therapy is that if stem cells impact their world and orchestrate tissue repair by excreting exosomes, then why not just skip the stem cells and inject the exosomes? The idea is simple enough, but also deeply flawed. Let me explain.
Stem cells work by detecting what needs to be done and then barking out commands via exosomes. So think of stem cells as the general contractor on a construction project to repair a house. The GC inspects the damage and sees what needs to be done. Maybe the plumbing is bad, the electrical is fried, and there’s structural damage. So from that assessment, he or she barks out orders to the plumber, the electrician, and the carpenter. The GC then inspects their work progress and alters what else is needed based on that progress. Maybe the electrician discovers foundation damage, so now a brick mason is also needed. Stem cells work in the same way.
A stem cell acts just like our GC. It detects what’s wrong and what needs to be fixed and how. It then barks out the orders via exosomes. It then continues to detect what’s wrong and what else is needed as the repairs continue.
Exosomes by Themselves Are Meaningless Stem Cell Orders Without Context
Think about this scenario. Let’s say that you just followed a GC around for a few days and recorded all of the orders he barked at his subcontractors. You then showed up to a damaged house, without any knowledge of how to be a general contractor, with your iPhone filled with the recorded orders. Your subcontractors are assembled there and wanting to be directed. You then play your mishmash of orders, none of which apply to what’s wrong with this damaged house. That’s the same as using exosomes from stem cells growing in culture.
Exosomes Are Isolated from Growing Cells
So let’s say you injured your knee and tore some of your ACL and MCL and damaged a bit of meniscus and cartilage to boot. Stem cells placed into each of these specific structures could quickly tell what’s wrong and begin issuing exosome orders to the surrounding subcontractor cells to help heal the damage. However, exosomes that are derived from cells growing in culture have none of that context. They’re just like our GC orders recorded on our iPhone and randomly spit back to our waiting subcontractors.
This is the seminal problem with exosomes derived from living cells in culture or even from amniotic fluid. They are random orders that have nothing to do with repairing your knee or your hip or your back. You need the GC to figure out what needs to be done and when. Hence, you need the stem cells in the mix, not just the random exosome orders.
Why are we seeing all of these exosome products hit the market? Growing stem cells in culture requires FDA drug approval per clinical indication. That means years and many millions of dollars for clinical trials. However, the companies selling exosomes believe that since they’re not using the stem cells, just using the exosomes sneaks around these drug-approval regulations. Is that correct? Not according to the FDA attorneys and experts I’ve consulted. They all say the same thing: these products are unapproved illegal drugs. So it’s just a matter of time until all of these exosome companies are shuttered by the FDA.
Shouldn’t we be selling all of those exosomes we create in Cayman every month in the U.S. instead of throwing them away? After all, what we’re discarding can fetch 40 times the price of gold for a 1–2 ml vial. Nope, that’s illegal. See above.
So now you can see why we throw out the exosomes that are produced when we culture stem cells. They’re just not as useful as the stem cells. However, none of this logic has prevented countless doctors from claiming that exosomes are the best thing since sliced bread. So where is the clinical evidence?
A search of the US National Library of Medicine today didn’t find a single study in patients with knee arthritis. In fact, there are only four animal studies published, and in three of them, exosomes helped arthritis, and in one they made it worse. There is no other research performed in real patients that demonstrates that exosomes work well for any orthopedic problem.
So why are doctors so excited? Sales reps are hawking this stuff like it’s magic. That’s how medicine works, boys and girls. Big commissions on expensive products push sales reps to convince gullible doctors who don’t know what they don’t know that they need to buy the magic pixie dust.
The upshot? We’ll continue pouring our exosomes down the drain, as stem cells are the general contractors that our patients need. In the meantime, we’ll let the guys illegally selling exosomes from cultured cells do the research to see whether an exosome shot works any better than much less expensive PRP or a same-day stem cell procedure. That is, if they don’t end up getting perp-walked first.