By Alvin Philipose, DC (Ret.), Clinic Director · Part of our guide to Stem Cells & Exosomes in Oklahoma
“Exosomes” is used as if it were one product. It isn’t. Exosomes are a class of extracellular vesicles, and what is inside them depends on the cell that made them, how those cells were grown, and how the vesicles were collected. Two vials labeled “exosomes” can have very little in common.
What an exosome is
Exosomes are vesicles roughly 30 to 150 nanometers across, released by nearly every cell type. They carry proteins, lipids, messenger RNA and microRNA between cells. They contain no nucleus and cannot replicate. Researchers often use the broader term “extracellular vesicles” (EVs) because isolation methods rarely separate exosomes cleanly from other vesicles.
1. Mesenchymal stromal cell (MSC) exosomes
The most studied category. MSCs are grown in culture and the vesicles they release into the culture medium are collected. The tissue source changes the profile:
- Bone marrow MSC exosomes: the longest research history; studied in models of tissue injury and inflammation.
- Adipose (fat) MSC exosomes: abundant source material; widely studied in skin and wound-healing models.
- Umbilical cord / Wharton’s jelly MSC exosomes: from donated birth tissue; the source most often sold commercially and the one most frequently named in FDA warning letters.
FDA status: no MSC exosome product is FDA-approved. Products intended to treat disease require an IND to be used in people.
2. Platelet-derived exosomes
Platelets release extracellular vesicles when activated, and these vesicles are part of why platelet-rich plasma (PRP) is studied for tissue repair. Lyophilized “platelet exosome” products made from pooled donor platelets are now under investigation. Your own PRP, prepared at the point of care with an FDA-cleared device, is a different category from a manufactured, donor-derived exosome product.
3. Placental and amniotic exosomes
Derived from placental, amniotic membrane or amniotic fluid tissues. Amniotic membrane used as a wound covering can qualify as a lower-risk “361” tissue product; injectable amniotic fluid or exosome preparations marketed for joints or systemic conditions generally do not meet the homologous-use criterion.
4. Plant-derived exosome-like nanoparticles
Vesicles isolated from plants such as ginger, grapefruit or rose. They appear mainly in topical skincare. Cosmetics are not FDA-approved before sale and cannot legally claim to treat disease.
5. Engineered and loaded exosomes
Exosomes produced from cell lines and loaded with a drug or nucleic acid. This is where much of the biotech investment is going, and these products are being developed as drugs through the standard IND and clinical trial process.
6. Your own circulating exosomes
Every person’s blood carries exosomes from their own cells. Measuring them is an active area of diagnostic research, for example as “liquid biopsy” markers. This is testing, not treatment.
Comparison at a glance
| Type | Source | Common use today | FDA-approved product? |
|---|---|---|---|
| Bone marrow MSC | Cultured donor cells | Research, trials | No |
| Adipose MSC | Cultured donor cells | Research, skin studies | No |
| Umbilical / Wharton’s jelly MSC | Donated birth tissue | Commercial marketing; frequent FDA warning letters | No |
| Platelet-derived | Donor or own platelets | Research; PRP biology | No |
| Placental / amniotic | Donated birth tissue | Wound coverings (tissue form) | No exosome product |
| Plant-derived | Plants | Topical cosmetics | Not applicable (cosmetic) |
| Engineered | Cell lines | Drug development | No |
Questions to ask about any exosome product
- What cell type and tissue source was used, and from how many donors?
- How were the vesicles isolated and counted, and is there a certificate of analysis?
- Was it tested for sterility, endotoxin and viral contaminants?
- Is it being given under an IND or a registered clinical trial? If so, what is the number?
How Venturis Clinic helps
We help patients understand the research and the regulatory status of what they have read about, and we help connect qualifying patients with lawful pathways such as registered clinical trials and expanded access. Compare the legal access pathways or call (405) 848-7246 for a free 15-minute discovery call.
Educational information only, not medical advice. There are currently no FDA-approved exosome products. Source: FDA Public Safety Notification on Exosome Products (Dec. 2019); 21 CFR Part 1271.