by The ISCT Exosomes Committee
The ISCT Annual Meeting held this year in Vancouver featured a significant event titled "MSC-EVs: Paving the Road to Regulatory Approval," focusing on the potential of mesenchymal stromal cell-derived extracellular vesicles (MSC-EVs) in clinical applications. This event brought together a range of experts to discuss the opportunities and challenges associated with MSC-EVs.
The event commenced with opening remarks from the organizers of this event, Bernd Giebel, PhD (University of Duisburg-Essen, Germany), Sai Kiang Lim, PhD (Paracrine Therapeutics, Singapore), and Elani Wiest, PhD (Mayo Clinic, United States). They set the stage for a series of insightful presentations and discussions.
Session I: Translating MSC-EV Products for Clinical Implementation featured Jacques Galipeau, MD (University of Wisconsin-Madison, United States), who provided insights into the biology of mesenchymal stromal cells (MSC) and discussed translational challenges and pitfalls. He highlighted the potential mode of action of MSCs by using the example of MSC-like cells in pregnancy, emphasizing their role in maintaining fetal-maternal tolerance. Overall, his keynote addressed the complexity and potential of MSC products in clinical settings, complexities that are inherent to the MSC-EV field.
Session II: Regulatory Challenges for EVs: Perspectives, Hurdles, and Solutions was chaired by Elani Wiest, PhD, and included a panel discussion with Andreas Marti, PhD (Swissmedic, Switzerland), Shinichi Noda, PhD (PMDA, Japan), and Laura Ricles, PhD (FDA, United States). The panelists explored the regulatory landscape, emphasizing the need for clear mechanisms of action, robust potency assays, and early regulatory engagement.
In Session III: Transitioning MSC-EV Manufacturing from Basic Research to Clinical Applications, Jon Rowley, PhD (RoosterBio Inc, United States), discussed bioprocess strategies for scaling up MSC-EV manufacturing, while Nisa Renault, PhD (Fujifilm Cellular Dynamics Inc, United States), presented on end-to-end thinking for successful EV manufacturing.
Session IV: Funding EV Research and Clinical Studies featured presentations by Byong Seung Cho (CEO, ExoCoBio, South Korea), who shared his experience in commercializing exosome technology for aesthetics and drugs, and Konstantin Glebov, PhD (University of Plymouth, United Kingdom), who addressed the challenges in attracting capital for EV clinical research amid drying investments.
The Closing Panel: Building a Roadmap for MSC-EVs: How Do We Move Forward From Here? included Bernd Giebel, PhD, Sai Kiang Lim, PhD, and Elani Wiest, PhD. The panelists summarized the event's discussions and emphasized the importance of a collaborative approach to overcome the regulatory, scientific, and financial hurdles in bringing MSC-EV therapies to market.
The event underscored the crucial steps required for clinical adoption and the future of EV research. The dedication and commitment of the speakers, panelists, and attendees highlighted the promising future of MSC-EV therapies.
The ISCT looks forward to continuing its efforts in fostering innovation and collaboration in the field of MSC-EVs.
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