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. Companies 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.

Right now a variety of exosome therapies are in clinical trials. One of the most notable is the trials of the Direct Biologics exosome product ExoFlo.

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.


5 thoughts on “Fact-checking exosome therapy: costs, risks, & lack of data”

  1. Agreed with Paul. I have ever done the experiment to modify MB231 cell line using siRNA and collect the exosomes in the conditioned media. Then cultured some cell lines like HEK203 and less malignant cancer cell lines (MB465) with the MB231-derived exosomes. Our results shown the increasing migration of HEK cell and less malignant cell-MB465 also changed to more aggressive. The tumor cell migration increasing could be the first step of the tumor metastasis. That is our direct evidence that exosomes derived from tumor cells with certain biomarkers could change the distant cell’s behavior.

  2. There is so much misinformation in this post. A lot has evolved since August 2022. Either update this post or delete it. There are countless studies proving the effectiveness of MSC Exosomes. You generalize “exosomes” here and make several false statements. “Exosomes change cell behavior”? Which kind of exosomes? Many cells secrete exosomes, it would be helpful if you would identify which where the exosomes were derived from? I know Mesenchymal Stem Cell Derived Exosomes don’t negatively change cell behavior and there are enough medical journals and studies all over the internet to prove they are in fact effective and safe. I could go on but I won’t. Warning to anyone reading this… keep researching and ignore this post. It’s all wrong and written because the author has his own agenda.

    1. @Chad, are you some exosome expert? What are your sources for your statements? You sound more like someone who sells exosomes and is grumpy that someone expects you to have data. There are no FDA-approved exosome therapies. There are no definitive clinical trials on safety and efficacy. That may change in coming years and I hope exosomes are approved for something but so far that’s not the case.

      1. Paul is right. There is no evidence that exosomes have any effects at all. They may be harmless, but they are also ineffective.

  3. I wonder if even if the exosomes are safe and clean they can get past the immune system to deliver any kind of benefit. There’s a big difference between theoretical and in practice in vivo.

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