EXOSOMES SCIENTIFIC SIGNATURE SERIES: PROGRAM SCHEDULE
Saturday, May 10, 2025
09:00–09:15
Opening Remarks
Sai Kiang Lim, PhD
Paracrine Therapeutics
Singapore
09:15–10:45
Session I: Defining the Active Components of the Secretome
Joint Session with ISEV
This session will examine the key active components within the secretome, including EVs, that drive the therapeutic efficacy of MSCs and non-MSCs such as immune cells. Speakers will explore how different cell sources contribute distinct paracrine factors, including proteins and RNA, and their roles in various therapeutic applications. The discussion will focus on identifying the most relevant active components, the potential synergy between soluble factors and EVs, and how these insights inform targeted therapies for specific diseases.
CHAIR & SPEAKER
Wei Seong Toh, PhD
National University of Singapore
Singapore
SPEAKER
Sai Kiang Lim, PhD
Paracrine Therapeutics
Singapore
SPEAKER
Massimiliano Gnecchi, MD, PhD
University of Pavia & IRCCS Policlinico San Matteo
Italy
Key Learning Objectives:
- What are the key active components in the secretome (soluble factors vs. EVs), and how do they contribute to therapeutic efficacy?
- How do different cell sources and disease indications influence the composition and function of EV subtypes?
- What is the relative importance of proteins versus RNA in mediating the therapeutic effects of MSC-EVs and non-MSC-EVs?
10:45–12:15
Session II: Limitations of Current Technologies in EV Production
This session will explore the challenges in evaluating the reproducibility and activity of MSC-EVs, highlighting the limitations of current methodologies. Speakers will discuss factors influencing MSC-EV production variability, the need for improved standardization, and the power of single EV analysis in understanding heterogeneity. Key topics include the identification of critical EV populations, biodistribution challenges, and mechanistic insights into EV function, all of which have significant implications for therapeutic applications and clinical translation.
CHAIR & SPEAKER
Ryang-Hwa Lee, PhD
Texas A & M University
United States
SPEAKER
Tobias Tertel, MSc
University Hospital Essen
Germany
Key Learning Objectives:
- What factors contribute to variability in MSC-EV production, and how can standardization be improved?
- What are the challenges in identifying, isolating, and functionally characterizing the most relevant EV populations?
- How do biodistribution and mechanism-of-action studies inform optimal delivery strategies and clinical translation?
12:15–13:15
Lunch
13:15–14:45
Session III: Clinical Trial Experiences with EV Therapies
This session will provide a global perspective on recent clinical trials utilizing extracellular vesicles (EVs) and secretome-based therapies. Speakers will share insights from early-phase trials across diverse therapeutic areas, including neonatal applications, ocular surface disease, and iPSC-derived MSC products. The session will highlight challenges and lessons learned in translating EV-based therapies from the lab to the clinic, emphasizing regulatory considerations, clinical outcomes, and future directions for therapeutic development.
CO-CHAIR
Massimiliano Gnecchi, MD, PhD
University of Pavia & IRCCS Policlinico San Matteo
Italy
CO-CHAIR
Elani Wiest, PhD
Mayo Clinic
United States
SPEAKER
Ali Djalilian, MD
University of Illinois Chicago
United States
SPEAKER
Eva Rohde, MD
Paracelsus Medical University
Austria
Key Learning Objectives:
- What are the key challenges and lessons learned from recent EV clinical trials across different therapeutic areas and regions?
- How do regulatory frameworks and clinical endpoints vary across global EV clinical trials, and what are the implications for future studies?
- What strategies can enhance the clinical translation of EV-based therapies, from cell sourcing to product standardization and patient outcomes?
14:45–16:15
Session IV: Moving EVs Forward
This session will build upon the previous sessions through a panel discussion. Advancing extracellular vesicles (EVs) into clinical applications faces numerous challenges, with the first major milestone being a First-in-Human trial. A strategic approach is essential to prioritize and address key hurdles at each stage of development. Critical challenges include identifying EVs' active components, overcoming technological limitations, and navigating clinical trials, with their impact evolving over time. Securing financial investment remains a persistent barrier, driven by the novelty and complexity of EVs, perceived risks, and the costly regulatory pathway—challenges that can be mitigated through strong scientific evidence.
CO-CHAIR
Sai Kiang Lim, PhD
Paracrine Therapeutics
Singapore
CO-CHAIR
Shuji Terai, MD, PhD, FAASLD
Niigata University
Japan
PANELIST
Jacques Galipeau, MD, PhD
University of Wisconsin-Madison
United States
PANELIST
Massimiliano Gnecchi, MD, PhD
University of Pavia & IRCCS Policlinico San Matteo
Italy
PANELIST
Tracy Heng, PhD
Monash University
Australia
PANELIST
Eva Rohde, MD
Paracelcus Medical University
Austria
PANELIST
Sowmya Viswanathan, PhD
University Health Network
Canada
PANELIST
Daniel Weiss, MD, PhD
University of Vermont
United States
Key Learning Objectives:
- What are the critical challenges in EV clinical development?
- How can the current state of the art in EV science and technology help to overcome these challenges?
- What are the nuances of developing a strategic path to EV clinical testing?
16:15–16:30
Closing Remarks
Co-Chairs will summarize key takeaways from the day and from each session. Where do we go from here and what can the ISCT Exosomes Committee do to move the needle?
Sai Kiang Lim, PhD
Paracrine Therapeutics
Singapore
Key Learning Objectives:
- What have these discussions concluded?
- What next steps need to be taken to advance the field?
- Where is there consensus, where is there still debate?