Exosome therapy

What it is

Exosomes are nanoscale vesicles that cells release to shuttle proteins and genetic material between them. The products clinics sell are typically harvested from donor stem cell cultures and given by infusion, injection or topically, promoted for regeneration, inflammation, hair and skin, and general anti-aging. No exosome product is FDA-approved for any use. In December 2019 the FDA issued a public safety notification after a cluster of patients in Nebraska developed serious bacterial infections following unapproved exosome products. A structural problem sits beneath the marketing: there is no standardized way to characterize an exosome preparation, as the International Society for Extracellular Vesicles sets out in its MISEV guidance, so two clinics selling "exosomes" may not be selling the same thing at all.