Expectations and Issues for Medical Application of Extracellular Vesicles: Considerations from the Viewpoint of Toxicology

Abstract

Extracellular vesicles (EVs) are being developed as therapeutics including regenerative and immune-modulatory therapies, and drug delivery system (DDS). Especially, among several stem cells, mesenchymal stem cells-derived EVs (MSC-EVs) have been focused as therapeutics for variety of human diseases including liver fibrosis, lung infection, kidney disorders. For the development of therapeutics of such stem cell-derived EVs, toxicity evaluation is the important first step in the nonclinical phase to ensure the safety of EV therapeutics. The values of MSC-EVs have been verified in a variety of experimental animal models, but the toxicity evaluation is not adequately performed. The aim of this talk is to evaluate toxicological profiles with MSC-EVs and other stem cell-derived EVs in according to the regulatory science.