Lilia Carolina Leon-Moreno, PhD
Postdoctoral Researcher
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco (CIATEJ) Jalisco, México
Andrés Caicedo, PhD
Universidad San Francisco de Quito
Quito, Ecuador
Samuel Couto, PhD
Lab Coordinator/Post-Doc
Childrens National Hospital/Fundação Pró-Sangue/HCFMUSP
Sao Paulo, Brazil
Alissen Haro, BSc
Laboratory Assistant
Universidad San Francisco de Quito
Quito, Ecuador
Abigail Benavides, MSc candidate
Universidad San Francisco de Quito
Quito, Ecuador
As an early-stage researcher in cell and gene therapy (CGT) based in Latin America, attending the ISCT 2025 Annual Meeting in New Orleans was a deeply enriching experience, both inspiring and grounding. It not only fulfilled my expectations, but it also exceeded them in every way. I am a postdoctoral researcher in Mexico focused on the development of mesenchymal stromal cells (MSCs) and MSC-derived exosomes in basic research and coming from a region where MSC banks are rapidly emerging and many institutions are eager to move into clinical translation [1]. This opportunity was crucial for understanding both the scientific advancements and the complex regulatory and ethical considerations necessary for responsible implementation. Being part of the ISCT 2025 Annual Meeting expanded my vision for the future of cell and gene therapies globally but also in our region. Immersing myself in cutting-edge discussions with leading scientists, clinicians, and regulatory experts gave me valuable insights around immunomodulation, potency attributes, and emerging consensus in the field of MSCs gave me valuable insights I now feel responsible for sharing with peers, institutions, and policymakers back home.
For those of us navigating the scientific and regulatory complexities of advanced therapies in under-resourced contexts, access to global platforms like ISCT is not only a personal milestone, but a regional imperative. The event not only showcased cutting-edge science but also fostered critical discussions that resonate deeply with the challenges and opportunities in my region. Several sessions stood out for their relevance to the current scientific landscape and for their potential to reshape the trajectory of cell-based therapies, particularly mesenchymal stromal/stem cell (MSC) products and their extracellular vesicles (EVs).
A particularly memorable highlight was the plenary session How to Succeed with Cell and Gene Therapies in a Complex Market, where Silviu Itescu, Chief Executive Officer and Managing Director of Mesoblast Limited, shared his invaluable experience with the recent FDA approval of Ryoncil, an MSC-derived ATMP for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) [2]. His reflections offered both a technical and strategic perspective on navigating the regulatory pathway in a challenging global market. The approval of Ryoncil marked a milestone for the MSC field; it was not just a regulatory success, but a renewed signal of hope. For many in the MSC community, including myself, it felt like “the light at the end of the tunnel.” It reignited investor interest and revalidated the clinical and commercial potential of MSC-based therapies [3].
One of the most thought-provoking moments came during the debate What Really Are Mesenchymal Stromal Cells? As the field moves toward consensus criteria and standardized reporting, questions remain about whether rigid definitions might inadvertently stifle innovation. The Delphi method was highlighted as a useful tool for building consensus in areas where scientific ambiguity persists—offering lessons for regulatory bodies in Latin America attempting to establish their own definitions and standards amid rapidly evolving science.
A recurring theme throughout ISCT 2025 was product consistency. The session Will MSC-EVs Fare Better Than MSCs?, tackled the intrinsic heterogeneity of MSC-EVs and how this variability impacts reproducibility and efficacy. Current and future strategies to mitigate donor and batch heterogeneity were presented, along with biodistribution studies that may shape future regulatory guidance. It also underscored that the most valuable therapy is the one that successfully meets regulatory standards and receives approval from health authorities. Because the true impact of any therapy lies in its ability to navigate and comply with regulatory frameworks to reach patients safely and effectively
In the session on Immunomodulatory Mechanisms and Potency Attributes of MSC Exosomes in Disease Treatment, the focus was on one of the most pressing questions in MSC-based therapies: how do these exosomes exert their effects, and how can we define their potency? The immunomodulatory role of MSC exosomes across various disease models was explored in detail, emphasizing the urgent need for robust critical quality attributes (CQAs) to support regulatory approval and clinical success. This is particularly important in Latin America, where regulatory frameworks for ATMPs are still evolving, and clearly defined potency assays could serve as pivotal tools for translating basic research into clinical impact.
On a broader scale, ISCT 2025 also provided a platform for deeper reflection on the regulatory disparities that persist across Latin America. While Brazil has emerged as a regional leader with a defined regulatory framework for advanced therapies, most countries—including my own—continue to face significant regulatory ambiguity. This not only hinders clinical translation and investment but also opens the door to unsafe, unproven interventions. Sessions such as Bridging the Gap: Enabling Equitable Patient Access to Advanced Therapies were a powerful reminder that access, safety, and ethics are global concerns and that improving them starts with knowledge-sharing and dialogue. This session emphasized that without inclusive regulatory environments and ethical frameworks, patients in low- and middle-income countries risk being left behind or worse, harmed by unregulated, unproven interventions.
In Latin America, regulatory ambiguity, limited GMP infrastructure, and a shortage of specialized research centers remain significant barriers. Yet this experience at ISCT 2025 reminded me of the importance of being an active participant in the global scientific community. Having the opportunity to attend was not just an academic privilege, it was a turning point and a responsibility. I return home inspired to disseminate this knowledge, foster regional awareness, and contribute to the development of a more robust, ethical, and collaborative ecosystem for advanced therapies in my country and region.
This experience reaffirmed that international engagement is not just beneficial, but essential. For early-career researchers like us, participating in global forums like ISCT empowers us to act as bridges—connecting local challenges to global solutions and helping ensure that innovation in regenerative medicine becomes a truly inclusive, global effort. The ESP team are now stronger advocates for science-based regulations and investment in advanced therapies in our region.
ISCT 2025 was more than a conference—it was a platform to connect local needs with global innovation and to inspire a new generation of scientists committed to equitable access and scientific excellence in cell and gene therapy.
Do you want to see more ISCT 2015 meetings’ highlights? We invite you to check the website and see the ISCT TV (with Spanish and Portuguese content!) [4]
References
1. Orozco-Solares TE, León-Moreno LC, Rojas-Rizo A, Manguart-Páez K, Caplan AI. Allogeneic Mesenchymal Stem Cell-Based Treatment Legislation in Latin America: The Need for Standardization in a Medical Tourism Context. Stem Cells Dev. 2022 Apr;31(7-8):143-162. doi: 10.1089/scd.2022.0013. Epub 2022 Mar 25. PMID: 35216516.
2. Christina Bach, MBE, LCSW, OSW-C. Remestemcel-L-rknd (Ryoncil®). Visited on May 22th, 2025. https://es.oncolink.org/tratamiento-del-cancer/oncolink-rx/remestemcel-l-rknd-ryoncil-R.
3. Blanc KL, Dazzi F, English K, Farge D, Galipeau J, Horwitz EM, Kadri N, Krampera M, Lalu MM, Nolta J, Patel NM, Shi Y, Weiss DJ, Viswanathan S. ISCT MSC committee statement on the US FDA approval of allogenic bone-marrow mesenchymal stromal cells. Cytotherapy. 2025 Apr;27(4):413-416. doi: 10.1016/j.jcyt.2025.01.005. Epub 2025 Jan 17. PMID: 39864015.
4. Home - ISCT 2025 New Orleans. https://www.isctglobal.org/annual-meeting/homepage