Exosome therapy

The human evidence is small and mostly about skin. In a split-face trial of 28 people, a solution of fat stem cell exosomes plus microneedling improved wrinkles, elasticity and overall appearance more than saline plus microneedling after 12 weeks [1]. For hair, a systematic review found 16 studies, but only one was in people [2]. An overview of 17 systematic reviews found that most exosome studies do not say clearly what was in the product or where it came from, and judged their methods weak [3].

Infused vesicles have been tested mainly in sick patients, not healthy people. In a placebo-controlled trial in 102 patients with COVID-19 respiratory failure, vesicles from bone marrow stem cells were safe, but did not significantly lower deaths at 60 days in the main analysis [4]. Hundreds of trials are registered, mostly for diagnosis or specific diseases [5]. No study has tested exosomes against aging in healthy people.

The FDA says no exosome product is approved, and that products used to treat disease are drugs and biologics that need approval first. In 2019 it reported serious adverse events in Nebraska patients given unapproved products sold as containing exosomes [6] [7].

• The FDA has approved no exosome product. Products sold to treat a disease or condition count as drugs and biologics that need approval, so clinic injections and IV drips are unapproved.
• In 2019 the FDA reported serious adverse events in Nebraska patients who received unapproved products marketed as containing exosomes.
• Products vary widely in source, purity and content, and what a vial contains is rarely verified, which raises the risk of contamination and infection.
• Topical exosome skincare is sold as a cosmetic, which needs no FDA approval before sale, so its content and claims are not checked the way a drug's are.
• There are no safety data for people who are pregnant, have cancer or have a weakened immune system, so any use belongs with a physician.