Charting the translational pathway: ISSCR best practices for the development of PSC-derived therapies

Stem Cell Reports 2026 Open access

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Authors: Jaqueline Barry, Elsa Abranches, Ricardo P. Baptista, Chris Barry, Catharina Brandsten, Kevin Bruce, Melissa K. Carpenter, Joy Cavagnaro, Lila R. Collins, Elizabeth Csaszar, Jennifer L. Dashnau, Denise de Villa
+42 more Kate Fynes, Michela Gabaldo, Jie Hao, Tamar Harel-Adar, Derek Hei, Claire Henchcliffe, Ana Hidalgo-Simon, Jennifer Suzanne Hollands, Deborah A. Hursh, Shawna M Jackman, Kilian Kelly, Jung-Hyun Kim, Hyunyoung Kim, Masahiro Kino-oka, Uma Lakshmipathy, Tyler Lamb, Stanley E. Lazic, Jeanne F. Loring, Tenneille E. Ludwig, Indumathi Mariappan, Christelle Monville, Joanne C. Mountford, Andras Nagy, Masanobu Kano, Graziella Pellegrini, Annelie Persson, Kendra M. Prutton, John E.J. Rasko, Dhruv Sareen, Yoji Sato, Anat Shnaiderman, Glyn Stacey, Clive N. Svendsen, Mark Tomishima, Alan Trounson, Sowmya Viswanathan, Shuyan Wang, Kirsty Wydenbach, Alex J. Zhang, Claudia Zylberberg, Jack Mosher, Kapil Bharti
DOI: 10.1016/j.stemcr.2025.102784
Cited by: 3
References: 4

Abstract

The successful translation of a stem cell-derived product from the laboratory into an approved medicine requires specific scientific, technical, and regulatory understanding. Since this knowledge base is fragmented across websites and publications, the ISSCR has developed a new resource, The Best Practices for the Development of Pluripotent Stem Cell-Derived Therapies. This comprehensive, interactive document, designed for academia and industry, addresses critical areas of the translational pipeline and key decision points for the successful translation to a licensed therapy. Uniquely, it provides a global perspective of the regulatory landscape while providing resources for critical processes and links to jurisdictional regulatory information.

Fields of Study & Subjects

Biomedical Ethics and Regulation Pluripotent Stem Cells Research CAR-T cell therapy research

Publication details

Journal / source
Stem Cell Reports
Publisher
Elsevier BV
Volume
21
Issue
2
Pages
102784–102784
Publication date
22 January 2026
Language
EN