An Exosome Sales Pitch: Separating Fact from Fiction
I often blog about what I see out there or what people send me. In this case, an exosome sales rep recently hit up a physician colleague. Let’s dive into what the rep wrote and said and debunk many of these claims.
Sales Reps
You can divide sales reps into two categories. The first is the professional type. They have years of experience and realize that placing the physicians they know into risky products or overselling and underdelivering will hurt their careers and relationships. These sales reps usually stay away from selling products like exosomes.
The second type is the kind we see here. This woman had held many jobs before she began pushing exosomes. IMHO, she doesn’t know which end is up based on the science or the regulations. This type of rep is usually hired by the companies selling exosomes.
The excerpts are from written information sent to my colleague from the second type of sales rep. What she pitched to my colleague is in bold, and my comments are below each statement.
Exosomes are powerful elements that can restore cells throughout your body. They enhance cell-to-cell communication, which is essential for overall cell health.
Partially true. Exosomes are the communication system between cells. While mostly accurate, this statement makes exosomes added by a doctor sound like a supplement your body needs for cell health. They are not.
Do we have evidence that exosomes restore cells? Not really. We do have some early evidence that one of the messages that exosomes can deliver is to repair cells. However, we also have evidence that exosomes are key in messages that cause and progress cancer (1).
Compared to adult stem cells, exosomes contain nearly three times the amount of growth factors. More growth factors means a better ability to restore and revitalize target cells.
This is a silly statement. Mesenchymal, other adult stem cells, and platelets excrete exosomes. They are the source for the exosomes being isolated, bottled, and sold.
To understand this better, the exosomes being sold today come in two flavors. The first is the company that takes amniotic fluid, places it in a fast centrifuge, which tends to concentrate exosomes and many other things, and then places that soup in a bottle marked exosomes. The second is growing mesenchymal stem cells in culture for a given time and bottling the media in which the cells are collected and processed (after centrifugation).
As shown above, X amount of exosomes containing growth factors are collected in both cases. If the doctor uses autologous MSCs that engraft at a site, those cells will produce far more exosomes over time than can be harvested using either of the above exosome manufacturing methods.
But the most important factor is that Exogenix has a COA that is registered with the FDA showing their process is verifiable, quantifiable, and able to be replicated. They take extreme pride in being the only manufacturer that’s legally recognized and registered as a 351(a) biologic drug utilizing human umbilical cord-derived exosomes with a Master File with the FDA. The COA which is a batch to batch COA also guarantees how many exosomes are in each vial every time, so there is consistency with treatments.
This statement IMHO is very deceiving and plays off physicians’ lack of knowledge about the FDA approval process. First, what’s being referenced is a 351 drug approval process, which is required BEFORE you can sell exosomes. Does Exogenix or any other company selling exosomes today have a 351 drug approval? NO. Is it legal to sell exosomes without such approval? NO. See these FDA letters to companies selling exosomes (FDA Letter 1, FDA Letter 2).
So, what’s being discussed if Exogenix doesn’t have the required FDA approval? A Drug Master File is one of the beginning steps in getting a 351 drug approval. It’s just filing to inform the FDA how you make your drug. The next step you need to get a 351 drug approval is filing an IND to perform clinical trials. That document itself takes 1-2 years to get right and approved. You then must pass Phase 1 trials for safety. Then, Phase 2 safety, efficacy, and dosing trials. Then, multiple phase 3 trials need to be passed. The FDA then reviews all of this data for a 351 drug denial or approval.
Does Exogenix even have that “Drug Master File”? On 2/2/24 I downloaded the FDA Master File List into Excel and searched for the product name “Exogenix”. Below is the result.
As you can see, there was no Drug Master File found under that name. If there is a drug Master File on this product, it’s not listed under that drug name.
Exosomes are considered a better option than PrP. With PrP, at a certain age unfortunately the cells start becoming less effective and most PrP is taking cells from one site of the body and injecting to the other. The majority of those searching for these kinds of treatments fall under that barriering category.
IMHO, yet another silly statement. PRP works by excreting exosomes and growth factors. While the growth factor content can decrease with age, to counteract that effect, you increase the concentration of the PRP. Pretty simple.
Exosome therapy improves the communication channels between cells to stimulate healing. For example, osteoarthritis is an extremely common degenerative joint condition. Exosome therapy supports healing by providing additional information from younger cells that your body needs.
Here, we have a treatment claim, which, IMHO makes Exogenix an unapproved drug product. In addition, for Exogenix or any exosome product, we have zero Randomized Controlled Trials showing efficacy in treating knee arthritis. We have several dozen positive RCTs for the treatment of knee arthritis.
The upshot? As you can see, this exosome sales pitch doesn’t hold water. If you are a physician getting hit up by a sales rep, please realize that the FDA has made clear that exosomes are illegal drug products that should not be sold nor used by physicians. Also realize that we have very little data that exosome products help arthrititis or pain.
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(1) Paskeh, M.D.A., Entezari, M., Mirzaei, S. et al. Emerging role of exosomes in cancer progression and tumor microenvironment remodeling. J Hematol Oncol 15, 83 (2022). https://doi.org/10.1186/s13045-022-01305-4
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NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.
