Exosomes: research and patient safety

What exosomes are

Exosomes are tiny bubbles, called extracellular vesicles, that cells release. They are roughly 30 to 150 nanometers across, about a thousand times thinner than a human hair. They carry proteins, fats and genetic messages such as RNA from one cell to another. You can think of them as part of the body’s cell-to-cell messaging system.

Why researchers are interested

• Messaging without cells. Some of the effects seen with stem cells may come from the signals they release, including exosomes, rather than from the cells themselves.
• Diagnostics. Exosomes in blood may one day help detect diseases such as cancer earlier.
• Drug delivery. Researchers are studying them as natural carriers for medicines.
• Aging research. Altered cell-to-cell communication is one of the recognized hallmarks of aging, so exosomes are studied in aging research too.

The gap between research and products

Scientific interest is not the same as proven treatment. Exosome products sold at clinics can differ widely in their source (for example MSCs, placenta or other tissue), how they are made, what they actually contain and how they are tested for purity. International research groups are still working on shared standards for describing and testing extracellular vesicles.

The FDA states that there are no FDA-approved exosome products. It has warned that unapproved stem cell and exosome products have been associated with serious adverse events. Check with the FDA, and with the regulator in the country where care would take place, for the latest status. U.S. status does not establish authorization in another country.

Be particularly careful when exosome products are advertised as proven treatments for many unrelated diseases, or as an “anti-aging” therapy.