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

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.

Authors

Institutions

Publication Details

Journal
Stem Cell Reports
Published
2026-01-22
DOI
https://doi.org/10.1016/j.stemcr.2025.102784
Primary Topic
Biomedical Ethics and Regulation
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

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

Elizabeth Csaszar, Jack Mosher, Joanne C. Mountford, Joy Cavagnaro et al.
Stem Cell Reports
Biomedical Ethics and Regulation
article

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

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

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.

Stem Cell ReportsVol. 21(2)
Israel Institute for Biological Research (IL), University of Modena and Reggio Emilia (IT), Scripps Research Institute (US), Cedars-Sinai Medical Center (US), Carter Center (US), National Institutes of Health (US), WiCell (US), University Health Network (CA), Roslin Institute (GB), Inserm (FR), California Institute for Regenerative Medicine (US), Keio University (JP), University of California, Irvine (US), Lunenfeld-Tanenbaum Research Institute (CA), Leo Pharma (Australia) (AU), Université Paris-Saclay (FR), Leiden University Medical Center (NL), PYC Therapeutics (Australia) (AU), Institute for Stem Cell Biology and Regenerative Medicine (IN), Korea National Institute of Health (KR), Beijing Agricultural Machinery Research Institute (CN), Cell and Gene Therapy Catapult (GB), Instituto Nacional de Administração, I. P. (PT), Takara (Sweden) (SE), Migration Institute of Australia (AU), Evanston Hospital (US), Monash Health (AU), Weatherford (United Kingdom) (GB), Stem Cells Australia (AU), Charles River Laboratories (United States) (US), Roslin Cells (United Kingdom) (GB), PowerCell (Sweden) (SE), Prioris.ai (Canada) (CA), ElectroCell (Sweden) (SE), Thermo Fisher Scientific (United States) (US), AstraZeneca (Sweden) (SE), International Society for Stem Cell Research (US), National Institute of Health Sciences (JP), National Institutes of Health Clinical Center (US), Shanghai Cell Therapy Research Institute (CN), Century Therapeutics (United States) (US), Bank of England (GB), Monash University (AU), Ajou University (KR), Université d'Évry Val-d'Essonne (FR), Scottish National Blood Transfusion Service (GB), Evotec (United States) (US)
Partnerships for the goals
Openalex Percentile: Top 82%
Biomedical Ethics and Regulation
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.