Mesenchymal Stromal Cell-Derived Exosomes and Extracellular Vesicles Across Therapeutic Indications A Structured Review of Published Preclinical and Early-Phase Clinical Study Designs, Administration Parameters, and Reported Outcomes

Important Notice and Disclaimers Read before proceeding. This document is a scientific literature review prepared for research and educational purposes only. It summarizes what independent investigators have published. It is not medical advice, not a treatment protocol, not a clinical guideline, and not a recommendation to use any product for any purpose. As of the date of this review, the U.S. Food and Drug Administration has not approved any exosome or mesenchymal stromal cell-derived extracellular vesicle product for any therapeutic indication. Exosomes intended to treat, diagnose, cure, mitigate, or prevent disease in humans are regulated as drugs and biological products under the Federal Food, Drug, and Cosmetic Act and Section 351 of the Public Health Service Act. In the United States they may lawfully be administered to humans only under an active Investigational New Drug (IND) application or an approved Biologics License Application (BLA). Nothing in this document should be read as a claim that any exosome or extracellular vesicle product is safe or effective for any use. All efficacy and safety statements are attributed to the cited authors and reflect their published reports, which have not been independently verified or confirmed by any regulatory authority and are subject to the methodological limitations discussed herein.