Extracellular vesicles derived from allogeneic human amniotic epithelial cells (hAEC-EV) are now being explored for their therapeutic potential in Crohn’s disease—a milestone that has taken more than 15 years of research, persistence, and learning. This talk will trace our team’s journey from cell-based (hAEC) to cell-free (hAEC-EV) therapies, highlighting both the breakthroughs and the roadblocks along the way. We will reflect on how early decisions around product attributes, process development, and regulatory strategy shaped the path forward—what worked well, what didn’t, and what we might do differently with the clarity of hindsight. Above all, this session will distill those experiences into practical, executable insights and key guidance documents for anyone navigating the complex translation of extracellular vesicle therapeutics from discovery to the clinic.