Abstract
Developing cellular therapies is not straightforward. This Perspective summarizes the experience of a group of academic stem cell investigators working in different clinical areas andaims to share insight into what we wished we knew beforestarting. These include (1) choosing the stem cell line and assessing the genome of both the starting and final product,(2) familiarity with GMP manufacturing, reagent validation, and supply chain management, (3) product delivery issues andthe additional regulatory challenges, (4) the relationship between clinical trial design and preclinical studies, and (5) the market approval requirements, pathways, and partnerships needed.
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