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Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framework intended to safely promote the clinical development of stem cell-based interventions (SCBIs) while subjecting commercialized unproven SCBIs to greater scrutiny and accountability. This article reviews ASRM's origins, explains its unprecedented scope, and assesses how it envisions the regulation of SCBIs. This analysis is used to highlight three key insights that are pertinent to the current revision of the ASRM: clarifying how the concept of safety should be defined and assessed in research and clinical care settings; revisiting risk criteria for review of SCBIs; and taking stronger measures to support the transition from unproven interventions to evidence-based therapies. Finally, the article reflects on lessons drawn from Japanese experiences in dealing with unproven SCBIs for international endeavors to regulate SCBIs.

Original publication




Journal article


Stem Cell Reports

Publication Date





1425 - 1434


Japan, clinical research, regenerative medicine, regulation, stem cell-based interventions, unproven therapy, Cell- and Tissue-Based Therapy, Clinical Medicine, Ethics, Clinical, Government Regulation, Health Policy, Humans, Japan, Practice Guidelines as Topic, Regenerative Medicine, Safety, Stem Cell Transplantation