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Chunk #42 — Clinical applications using human iPSC products

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Induced pluripotent stem cell technology: a decade of progress.
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The allogeneic iPSC approach could also bring down the cost for iPSC-based cell therapy. Excluding high startup cost, each iPSC line costs ~$10,000–20,000 to produce169. Meeting cGMP requirements increases this cost substantially170. Costs are even higher, by approximately $800,000169, to generate an iPSC-derived tissue product suitable for clinical use (e.g., differentiation of iPSC-neuronal cells for CVA, iPSC-cardiomyocytes for MI, or iPSC-RPE cells for macular degeneration). Banking iPSCs for allogeneic transplant has the potential to reduce cost because one production may be used for multiple patients. To facilitate allogeneic transplant, the effectiveness of conventional immunosuppressive protocols and newer regimen of co-stimulatory blockers for inducing immunotolerance will need to be improved in preclinical and clinical settings171,172. Moreover, understanding how pluripotent stem cells interact with the immune system and why they may be more tolerance-inducing than other transplanted cells may lead to the identification of new immunosuppressive mechanisms and strategies163. Furthermore, transplantation to immune-privileged sites may serve as a possible strategy to overcome immune rejection. Incorporating recent advances in genome editing strategies to create universally accepted donor cells could be another alternative approach173.