Exosome therapy

Exosomes are extracellular vesicles of 30–150 nm diameter that originate from the endosomal multivesicular body pathway and carry a cargo of proteins, lipids, mRNAs, miRNAs, and other non-coding RNAs that can modulate gene expression and cell behaviour in recipient cells. In aging research, exosomes derived from young plasma or from mesenchymal stem cells (MSC-EVs) have shown rejuvenating effects in rodent models — improving cardiac function, cognitive performance, and tissue regeneration — and are proposed as a cell-free alternative to plasma transfusion or stem cell therapy with potentially lower immunogenic risk. Regulatory classification is contested: the FDA considers most exosome products as biologics subject to IND application for clinical use, and in 2019 issued a safety alert warning that exosome products marketed for anti-aging, orthopedic, or hair loss indications outside clinical trials have not demonstrated safety or efficacy. The clinical evidence base consists primarily of small pilot studies and case series; controlled randomised trial data in aging are absent. Standardisation of isolation method, cargo characterisation, potency assays, and dosing remains an unresolved challenge across the field, and exosome products sold directly at clinics should be viewed with significant caution.