Cell-therapy clinical-trial pipeline

FDA cell-therapy regulatory pathway: Phase 1 safety (n~10-30) → Phase 2 dose-finding (n~50-200) → Phase 3 efficacy (n~500+) → BLA approval. Examples: CAR-T (Kymriah 2017 first-approved); MSC (Prochymal 2012 Canada); RPE retinal-pigment…