From laboratory to clinic: Bridging regulatory and manufacturing gaps in stem cell-based therapies

Advanced therapy medicinal products (ATMPs), encompassing therapies derived from mesenchymal stem cells, induced pluripotent stem cells, and their extracellular vesicles, hold substantial transformative potential for clinical applications. However, their translation from bench to bedside and eventual commercialization is hindered by considerable scientific, manufacturing, and regulatory challenges. This review examines these challenges using a structured framework that synthesizes evidence from