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

Eva Rohde
 | Marta Monguió-Tortajada 



  • 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


Jonathon Anderson | Francesc E. Borras | Benedetta Bussolati | Edit Buzas | Dave Carter | Rachel Ciccocioppo | Owen Davies | Juan M. Falcon-Perez | Bernd Giebel | Mario Gimona | Rebecca Lim | Sai Kiang Lim |  Anna Nowocin | Lorraine O'Driscoll | Xenia Sango | Ralf Sanzenbacher | Hidetoshi Tahara | Clotilde Thery | Wei Seong Toh | Marca Wauben | Daniel Weiss | Kenneth Witwer

Authority Representatives
Ilona Reischl | Ralf Sanzenbacher