Regulatory considerations for developing a phase I investigational new drug application for autologous induced pluripotent stem cells‐based therapy product

Abstract Induced pluripotent stem cells (iPSC)‐based therapies have been hailed as the future of regenerative medicine because of their potential to provide treatment options for most degenerative diseases. A key promise of iPSC‐based therapies is the possibility of an autologous transplant that may...

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Bibliographic Details
Main Authors: Balendu Shekhar Jha, Mitra Farnoodian, Kapil Bharti
Format: Article
Language:English
Published: Wiley 2021-02-01
Series:Stem Cells Translational Medicine
Subjects:
GLP
GMP
IND
Online Access:https://doi.org/10.1002/sctm.20-0242