Best Practices for the Development
of Pluripotent Stem Cell-Derived Cellular Therapies
A comprehensive, interactive, international document.
Designed for academic and industry scientists and regulators.
Addresses critical areas of the translational pipeline.
Highlights key decision points essential for successful translation to a licensed therapy.
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Steering Committee and Working Groups
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Jacqueline Barry (co-chair), Cell and Gene Therapy Catapult, UK
Kapil Bharti (co-chair), National Institutes of Health, US
Ricardo Baptista, SmartCella, Sweden
Melissa Carpenter, Carpenter Consulting, US
Derek Hei, Kenai Therapeutics, US
Ana Hidalgo-Simon, Leiden University Medical Center, Netherlands
Deborah Hursh, Hursh Cell Therapy Consulting, LLC, US
Jung-Hyun Kim, Ajou University, Korea
Tenneille Ludwig, WiCell Research Institute, US
Hideyuki Okano, Keio University School of Medicine, Japan
John Rasko, Royal Prince Alfred Hospital, Australia
Yoji Sato, National Institute of Health Sciences, Japan
Glyn Stacey, International Stem Cell Banking Initiative, UK
Clive Svendsen, Cedars Sinai Regenerative Medicine Institute, US
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Kapil Bharti, NIH, US (co-chair)
Tenneille Ludwig, WiCell, US (co-chair)
Jacqueline Barry, CGT CATAPULT, UK
Catharina Brandsten, Takara Bio Europe, Sweden
Elizabeth Csaszar, Notch Therapeutics, Canada
Indumathi Mariappan, LV Prasad Eye Institute, India
Mark Tomishima, Blue Rock Therapeutics, US
Alex Zhang, Zephyrm, China
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Derek Hei (co-chair), Kenai Therapeutics, US
Jennifer Hollands (co-chair), Cell Therapies Pty Ltd, Australia
Ricardo Baptista, SmartCella, Sweden
Melissa Carpenter, Carpenter Consulting, US
Jennifer Dashnau, Century Therapeutics, US
Kate Fynes, eXmoor pharma, UK
Mashiro Kino-oka, University of Osaka, Japan
Dhruv Sareen, Cedars-Sinai Medical Center, US
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Jung-Hyun Kim (co-chair), Ajou University, Korea
Glyn Stacey (co-chair), ISCBI, UK
Elsa Abranches, ViSync Technologies, Portugal
Ricardo Baptista, SmartCella, Sweden
Jie Hao, National Stem Cell Resource Center, China
Hyunyoung Kim, KNIH, Korea
Tenneille Ludwig. WiCell, US
Joanne Mountford, SNBTS, UK
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Jeanne Loring (co-chair), Aspen Neuroscience and Scripps Research,
US
Yoji Sato (co-chair), National Institute of Health Sciences, Japan
Joy Cavagnaro, Access Bio, US
Lila Collins, CIRM, US
Shawna Jackman, Charles River, US
Cristelle Monville, I-Stem, France
Andras Nagy, LTRI, Sinai Health, Canada
Clive Svendsen, Cedars Sinai, US
Consultant: Michaela Sharpe, Moare Solutions, UK
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Ricardo Baptista (co-chair), SmartCella, Sweden
Uma Lakshmipathy (co-chair), Thermo Fisher, US
Elsa Abranches, ViSync Technologies, Portugal
Kevin Bruce, Roslin, UK
Tamar Harel-Adar, MatriCelf, Israel
Annelie Persson, AstraZeneca, Sweden
Anat Shnaiderman, MatriCelf, Israel
Shuyan Wang, Zephrym, China
Claudia Zylberberg, Akron Bio, US
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Claire Henchcliffe (co-chair), University of California, Irvine, US
John Rasko (co-chair), Cynata Therapeutics Limited, Australia
Stanley Lazic, Prioris.ai Inc
Hideyuki Okano, Keio University, Japan
Graziella Pellegrini, University of Modena and Reggio Emilia Modena, Italy
Alan Trounson, Catherics and Monash University, Australia
Sowmya Viswanathan, UHN, Canada
Kirsty Wydenbach, Weatherden, UK
Consultant: Roger Barker, University of Cambridge, UK
We would like to thank the many people who took the time to review the document. We would especially like to thank the regulators from across the globe for their critical review and feedback.
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Jacqueline Barry (co-chair), CGT Catapult, UK
Deborah Hursh (co-chair), Hursh Consulting, US
Michela Gabaldo, Evotec, Italy
Ana Hidalgo-Simon, LUMC, Netherlands
Kilian Kelly, Cynata, Australia
John Rasko, Royal Prince Alfred Hospital, Australia
Yoji Sato, National Institute of Health Sciences, Japan
Sowmya Viswanathan, University Health Network, Canada
The ISSCR Standards Initiative is made possible through contributions by:
The ISSCR's Standards for Human Stem Cell Use in Research are strictly copyrighted by the society. No part of this document may be produced in any form without written permission of The International Society for Stem Cell Research. Contact isscr@isscr.org for more information.
©2025 by The International Society for Stem Cell Research. All rights reserved.