作者: Christopher A. Bravery
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摘要: The promise of off-the-shelf cellular therapeutics (CTPs) based on allogeneic induced pluripotent stem cells (iPSCs) may be hindered by alloimmunity, leading many to suggest that such products could a series human leukocyte antigen (HLA)-typed iPSC lines allowing at least some degree tissue matching. While sound scientific principles, this suggestion presupposes other immune responses will not limiting. Technically approach would present number major challenges, the first being development suitably reliable reprogramming method amenable validation results in highly consistent lines. Further, resulting array HLA-typed iPSCs need shown capable manufactured into same CTP and exhibit comparable quality, safety, efficacy. When enormities these challenges are laid out, it becomes apparent manufacturing product unprecedented. Given uncertainties lack clinical experience with iPSC-based CTPs time, financial costs commercial risks do appear acceptable.