Regulatory Affairs and Clinical Use of EV-based Therapeutics Task Force


The TF is composed of global experts whose experience spans academia, clinical development, industry, and regulatory affairs in the EV research and therapy field. The Task Force is focusing on the discovery of EV-based therapeutic strategies and their clinical translation. The identification of the relevant regulatory guidance and their application to EVs as investigational new drugs (INDs) in clinical studies is a major goal as well as to support safe and effective EV-based treatment concepts worldwide.

Working Groups

Two subgroups should facilitate bench-to-bedside transfer by 1) identifying analytical tools for potency measurement of EV’s safety and efficacy and 2) define reporting standards that relate to the modification of EVs to enhance therapeutic potency or improve and monitor biodistribution, targeting and cellular uptake. In a long-term perspective, these subgroups “Biological standardisation and development of international potency standards for EVs” and “Reporting Standards for Modified Extracellular Vesicles” are focusing on the acceleration of translational research and clinical evaluation of EV-based therapeutics.

Chair Contact Info


Benedetta Bussolati | Edit Buzas | Rachel Ciccocioppo | Owen Davies | Juan M. Falcon-Perez | Qing-Ling Fu | Bernd Giebel | Mario Gimona | Rebecca Lim | Sai Kiang Lim | Lorraine O'Driscoll | Xenia Sango | Ralf Sanzenbacher | Hidetoshi Tahara | Clotilde Thery | Wei Seong Toh | Marca Wauben | Daniel Weiss | Kenneth Witwer | Sun Young Lee | Pascale Zimmermann

Authority Representatives
Ilona Reischl | Ralf Sanzenbacher | Anna Nowocin


Other Outputs

  • Task Force representation at the ISCT Annual Meeting (Paris, France 05-06/2023); contribution to the IOC, and featuring of  the "Exosomes Translation Event," (co-organized by ISCT and ISEV members;
  • Task Force representation at the ISEV Annual Meeting (Seattle, US, 05/2023); plenary talk ( ) and overview of the Task Force activities “Regulatory Affairs and Clinical Use of EVs” from 2019-2023. Click here to view the presentation. 
  • Task Force representation at Gordon Research Conference (Maine, US, 07/2022)
  • Task Force representation at ISCT (San Francisco, US, 05/2022); contribution to the proceedings article: A report on the ISCT 2022 Scientific Signature Series, “Therapeutic advances with native and engineered human extracellular vesicles.”
  • Contribution to MISEV2022/Therapeutics section
  • E. Rohde is member of the ISCT exosome committee, ISEV/ISCT joint planning activities of scientific meetings

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