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
Past meetings
| Date | No. | PressRelease | Agenda/List of Handouts | Minutes |
|---|---|---|---|---|
| September 22, 2022 | 6th mtg. | Press Release | Agenda/List of Handouts | Minutes【PDF：270KB】 |
| June 20, 2022 | 5th mtg. | Press Release | Agenda/List of Handouts | Minutes【PDF：348KB】 |
| March 30, 2022 | 4th mtg. | Press Release | Agenda/List of Handouts | Minutes【PDF：408KB】 |
| January 17, 2022 | 3rd mtg. | Press Release | Agenda/List of Handouts | Minutes【PDF：473KB】 |
| October 4, 2021 | 2nd mtg. | Press Release | Agenda/List of Handouts | Minutes【PDF：446KB】 |
| August 4, 2021 | 1st mtg. | Press Release | Agenda/List of Handouts | Minutes【PDF：507KB】 |
Outcome Documents
Report on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes [403.34KB]
Quality and Safety Considerations for Therapeutic Products Based on Extracellular Vesicles.
Takakura Y, Hanayama R, Akiyoshi K, Futaki S, Hida K, Ichiki T, Ishii-Watabe A, Kuroda M, Maki K, Miura Y, Okada Y, Seo N, Takeuchi T, Yamaguchi T, Yoshioka Y.
Pharm Res (2024). https://doi.org/10.1007/s11095-024-03757-4