Application of Induced Pluripotent Stem Cells in Drug Discovery and Regenerative Medicine

Abstract

Since the first successful generation of induced pluripotent stem cells (iPSCs) by Yamanaka et al. in 2007, there has been progress in related research, along with increasing technological advances. Expected applications in drug development include use of human-derived iPSCs for drug safety evaluation and patient-derived iPSCs for pathological analysis, and for exploration and development of therapeutic drugs. Efforts toward practical application are underway, with clinical trials already initiated for some cellular- and tissue-based products using iPSCs. However, iPSC application involves issues requiring special attention in the context of their characteristics. The Pharmaceuticals and Medical Devices Agency has compiled current considerations for iPSC application in drug discovery and regenerative medicine based on published information on iPSC application and our experience with consultations regarding iPSC use for drug development, and for cellular- and tissue-based products. In this review, we present an overview of these considerations to help facilitate further drug development.