Fact-checking exosome therapy: costs, risks, & lack of data

Exosome therapy is a still-experimental cell therapy approach aimed at treating specific diseases using secretions from cells. It’s novel since most attention on cell therapies has been given to using the actual cells themselves.

In addition, this approach is a newer idea than using cells as the drug to treat diseases. Interestingly, the term “cell therapy” has evolved to include not just living cells but also biologics made from cells.

Today’s post answers all your key questions on exosome therapy.

What is exosome therapy? | FDA and unproven exosome therapies | Exosome therapy cost $5000 | Exosome Risks & Side EffectsClinical TrialsReferences

model of an exosome, exosome therapy
A useful model of an exosome. Some specific features could be important for exosome therapy, but have to be proven. Part of Fig. 1 of Muthu, et al. Stem Cell Invest. 2021, which is the third item in reference list below.

What is exosome therapy?

Let’s start with exosomes themselves. Exosomes are tiny secreted cellular bubbles full of stuff from inside cells.

Imagine if a little bubble formed on your arm and popped off. Inside would be bits of skin, hair, muscle, blood, etc. Something similar happens continuously with cells. They shed little bubbles of their insides. That’s exosomes.

Since we grow cells regularly in the lab in a liquid media, the initial step in harvesting exosomes is as simple as collecting the used media that cells have been living in for days.

Then exosomes can be purified from that liquid, which we scientists call, “conditioned media.”

Exosome therapy is defined as using exosomes to try to treat any number of diseases. Cmpanies that manufacture exosome products often get the exosomes from either lab-grown cells or more rarely actual biologics from people such as amniotic fluid.

Exosome clinical trial listing map
Exosome clinical trial listing map. Clinicaltrials.gov.

FDA and unproven exosome therapies

The FDA has also not approved any exosome therapy.

The agency has repeatedly defined exosomes as drugs. For that reason, an FDA IND is required to do clinical trials and FDA drug-level approval is needed to legally market any exosome therapy for clinical use.

Unfortunately, while clinical use of exosome therapy is not proven yet, many have already been selling such therapies. What drew the most attention is marketing of exosomes for COVID-19. There is still no proof that exosomes help COVID patients.

Exosomes have also been marketed for many other conditions and for cosmetic uses. Here again, there is no good evidence that this is useful or even clearly safe.

Supposed exosome hair therapy has drawn a lot of attention as has claims about anti-aging using exosomes. However, I can’t find solid data to back up either of those ideas.

Exosome therapy cost $5,000

Exosome therapy is expensive. A survey I did of online prices from those selling exosome therapies yielded an average price of about $5,000.

Those selling exosome treatments are often charging thousands of dollars for something that likely costs only about $50-$100 dollars per dose to make. Talk about a markup.

It used to be that the cost of exosomes was far less than stem cell therapies, but now they aren’t so different. See my recent post on stem cell therapy cost.

Exosome treatment risks & side effects

Like any biological material, exosomes will pose risks when used clinically. Since exosomes are generally derived from human cells and tissues, there is the risk of infection due to contamination.

This could be bacterial, viral, or fungal.

One challenge with prepping exosomes is that you hope to have a sterile product, but key methods often used to sterilize biologics would likely destroy exosomes.

Another risk is that exosomes could also change cell behaviors inside the body in negative ways. For instance, it’s possible that exosomes could encourage growth of precancerous cells. On the other hand, exosomes might harm or kill good cells too. We just don’t know enough about how the body reacts to supposed exosome therapy.

Much of the risk will also depend on who makes the exosome product and how careful and knowledgable they are.

The FDA reported some patients were harmed in Nebraska from unproven exosome therapies.

Overall, while I’m not a physician and can’t give medical advice, as a stem cell biologist I would recommend against getting exosome therapy at this time. The main reasons are unknown risks, lack of clear benefit, no FDA approval, and expense.

Clinical trials

The key way to get to a clearer picture is through high-quality clinical trials.

I just did a clinical trial search on Clinicaltrials.gov and found 279  exosome clinical trial listings. Not all of these are actual interventional trials.

Even among the trials, some have sponsors who may already be charging.

Hopefully some exosome therapies will ultimately be proven safe and effective in the next 5-10 years.

References

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