Host: The Japanese Society of Toxicology
Name : The 49th Annual Meeting of the Japanese Society of Toxicology
Date : June 30, 2022 - July 02, 2022
Extracellular vesicles (EVs) are heterogeneous populations of naturally occurring nano to micro-sized membrane vesicles released by essentially all cell types. Recent increasing evidence supports that EVs, including exosomes and microvesicles, mediate intercellular communication that contributes to diverse aspects of human physiology and pathophysiology. A lipid bilayer protects the EV cargo of nucleic acids and proteins from degradation and permits signaling over long distances. Therefore, EV composition profiles and cargos are attractive disease biomarkers, and stem-cell derived EVs have shown great promise in becoming a novel cell-free regenerative medicine. Especially, mesenchymal stem cells (MSC)-derived EVs have been suggested and highlighted as therapeutics for variety of human diseases, but the toxicity evaluation is still limited. For the development of therapeutics, pharmacology and toxicology evaluation is the important step in the nonclinical phase to ensure the safety of EV therapeutics. Recently, it has been demonstrated that the toxicological and bio-distribution profiles of MSC-EVs have been evaluated using different species of animals. Furthermore, our team are developing an EV therapeutics for lung diseases in Japan. In this session, we will discuss the current regulatory questions and challenges in toxicology study design for EV therapeutics as a new modality.
