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Regulatory Considerations for Autologous iPSC-based Therapies

Due to their potential to treat degenerative diseases, many have hailed induced pluripotent stem cell (iPSC)‐based therapies as the future of regenerative medicine. The possibility of an autologous transplant that engraftments well in the long‐term represents a key promise of iPSC‐based therapies; however, the clinical translation of autologous iPSC‐based therapies has been slow due to the lack of a pre‐defined regulatory pathway. Now, researchers led by Kapil Bharti (National Eye Institute, National Institutes of Health, Bethesda, MA, USA) outline regulatory considerations for the development of autologous iPSC‐based products and discuss the challenges associated with the clinical manufacturing of autologous iPSCs and their derivatives. For all the details, see STEM CELLS Translational Medicine now!