Autologous Exosomes for Human Therapeutics: Biological Basis, Isolation Methodologies, Kit Development, and Translational Requirements

Abstract

Autologous exosomes are extracellular vesicles obtained from a patient and intended for administration to the same patient. They are being investigated as cell-free biological materials for regenerative medicine, wound repair, aesthetic medicine, hair restoration, reproductive medicine, orthopaedic therapy, drug delivery, and immunomodulation. Their therapeutic rationale is based on extracellular vesicles' ability to transfer proteins, lipids, messenger RNA, microRNA, and other signalling molecules between cells. However, autologous origin does not establish complete safety, purity, therapeutic potency, or regulatory approval. The composition of a patient-derived preparation may vary depending on the source tissue, disease state, age, medications, inflammation, collection procedure, and isolation method. Current evidence also demonstrates that many published clinical studies involve allogeneic MSC-derived or platelet-derived EVs rather than autologous exosomes. Therefore, an autologous exosome kit should be developed as a validated, patient-specific small extracellular vesicle processing system, incorporating closed collection, controlled separation, purification, characterisation, contamination control, stability assessment, and indication-specific potency testing.