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Regulatory Science/The Science Board/Standard Development

Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes

Background

Extracellular Vesicles (EVs), such as exosomes, are thought to be responsible for intercellular communication through the functional molecules they contain. Since it has been reported that EVs cause some of the paracrine effects of mesenchymal stem cells (MSCs) which have tissue repair properties, the practical use of EVs secreted by MSCs derived from bone marrow, adipose, or umbilical cord is expected as a notable next-generation therapeutic tool without using cells.
The subcommittee discusses evaluation of safety against viruses and other infectious factors, quality characterization of active ingredients, ensuring consistency in manufacturing, manufacturing process control, evaluation strategies for non-clinical studies, and points to consider in clinical trials.
 

Member List

Member List of the Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes