Abstract

Small extracellular vesicles (sEVs), commonly referred to as exosomes, have emerged as novel therapeutic tools in regenerative and esthetic medicine. A critical decision in their clinical application is the choice between autologous and non-autologous products, as this distinction directly impacts safety, immunocompatibility, efficacy, and regulatory compliance. This review analyzes the immunological profile and biological risks associated with exosomes’ clinical use according to their cellular origin, addressing persistence, pathogen transmission, delivery routes, and regulatory classification. Furthermore, we highlight the strategic role of blood centers and biobanks in producing high-safety allogeneic sEVs, especially those derived from human platelets and mesenchymal stromal cells expanded in xenofree conditions. While autologous exosomes offer maximal immunological safety, standardized allogeneic strategies free from animal-derived components represent a scalable and regulatory-compatible alternative for modern regenerative therapies.