Standards

The ISSCR Standards Initiative was launched in 2021 as an international collaboration to strengthen the pipeline of research and applications to human health. The initiative published Standards for Human Stem Cell Use in Research in 2023; since being adopted by publications, institutions, and funders all over the world. Subsequent best practices are currently underway to help organizations navigate the regulatory landscape and process of clinical translation.

Standards for Human Stem Cell Use in Research

This document identifies quality standards and outlines basic core principles for the laboratory use of both tissue and pluripotent human stem cells and the in vitro model systems that rely on them. Overall, the emphasis of this document is creating a set of recommendations that, when taken together, establish the minimum characterization and reporting criteria for scientists, students, and technicians in basic research laboratories working with human stem cells.

Click the button below to explore:

  • PDF versions of the Standards in English and Japanese

  • An online, interactive version of the Standards

  • A fillable Reporting Practices Checklist PDF

  • Steering Committee

    Tenneille Ludwig, Co-Chair
    WiCell Research Institute (USA)

    Peter Andrews, Co-Chair
    The University of Sheffield (UK)

    Ivana Barbaric
    The University of Sheffield (UK)

    Nissim Benvenisty
    Hebrew University (Israel)

    Madeline Lancaster
    MRC Laboratory of Molecular Biology (UK)

    Christine Mummery
    Leiden University Medical Center (Netherlands)

    Martin Pera
    The Jackson Laboratory (USA)

    Yoji Sato
    National Institute of Health Sciences (Japan)

    Glyn Stacey
    International Stem Cell Banking Initiative (UK)

    Christine A. Wells
    University of Melbourne (Australia)

    Tongbiao Zhao
    Institute of Zoology Chinese Academy of Sciences, Beijing Institute for Stem Cell and Regenerative Medicine, Beijing (China)

    Working Groups

    Basic Characterization Standards

    Glyn Stacey, Co-Chair
    International Stem Cell Banking Initiative (UK)

    Tenneille Ludwig, Co-Chair
    WiCell Research Institute USA)

    Jeremy Crook
    The University of Sydney, Chris O’Brien Lifehouse, The University of Wollongong (Australia)

    Laurence Daheron
    Harvard Stem Cell Institute (USA)

    Jon Draper
    Stem Cell Network (Canada)

    Lyn Healy
    Francis Crick Institute (UK)

    Andreas Kurtz
    Fraunhofer Institute for Biomedical Engineering, Berlin Institute of Health at Charité, (Germany)

    Undifferentiated Stem Cells and Pluripotency

    Peter Andrews, Co-Chair
    The University of Sheffield (UK)

    Martin Pera, Co-Chair
    The Jackson Laboratory (USA)

    Lyn Healy
    Francis Crick Institute (UK)

    Maneesha Inamdar
    Jawaharlal Nehru Centre for Advanced Scientific Research, Institute for Stem Cell Science and Regenerative Medicine (India)

    Tenneille Ludwig
    WiCell Research Institute (USA)

    Noriko Shimasaki
    Center for iPS Research and Application, Kyoto, Kyoto Prefectural University of Medicine, Nagoya University, Japan, National University of Singapore, Singapore (Japan)

    Austin Smith
    University of Exeter (UK)

    Genomic Characterization

    Ivana Barbaric, Co-Chair
    The University of Sheffield (UK)

    Tenneille Ludwig
    WiCell Research Institute (USA)

    Peter Andrews
    The University of Sheffield (UK)

    Nissim Benvenisty
    Hebrew University (Israel)

    Martin Pera
    The Jackson Laboratory (USA)

    Yoji Sato
    National Institute of Health Sciences (Japan)

    Claudia Spits
    Vrije Universiteit Brussel (Belgium)

    Tongbiao Zhao
    Institute of Zoology Chinese Academy of Sciences, Beijing Institute for Stem Cell and Regenerative Medicine, Beijing (China)

    Stem Cell-derived Model Systems

    Madeline Lancaster, Co-Chair
    MRC Laboratory of Molecular Biology (UK)

    Christine Mummery, Co-Chair
    Leiden University Medical Center (Netherlands)

    Anita Bhattacharyya
    University of Wisconsin-Madison (USA)

    Jeremy Crook
    The University of Sydney, Chris O’Brien Lifehouse, The University of Wollongong, NSW, Australia (Australia)

    Meritxell Huch
    Max Planck Institute of Molecular Cell Biology and Genetics, and Center for Systems Biology, Dresden(Germany)

    Kim Jensen
    Novo Nordisk Foundation Center for Stem Cell Medicine,

    University of Copenhagen (Denmark)

    Prisca Liberali
    Friedrich Miescher Institute for Biomedical Research (Switzerland)

    Matthias Lutolf
    Swiss Federal Institute of Technology (EPFL) (Switzerland)

    Jihwan Song
    CHA University, and iPS Bio, Inc. (Korea)

    Christine A. Wells
    University of Melbourne (Australia)

    Tongbiao Zhao
    Institute of Zoology Chinese Academy of Sciences, Beijing Institute for Stem Cell and Regenerative Medicine (China)

    Supported by ISSCR Staff

    Tyler Lamb, Director of Policy

    Jack Mosher, Scientific Advisor

Clinical Best Practices for the Development of PSC-Derived Cellular Therapies

Currently underway, this initiative will provide recommendations to facilitate and streamline the development of PSC-based cellular therapies regardless of regulatory jurisdiction. It will also provide detailed guidance at key product development pain points.

Working Groups and Focus Areas

An international group of leaders is currently developing this document. The Task Force is organized in working groups, led by the steering committee. Working group areas of focus includes:

  • Starting Materials

  • Banking

  • Ancillary Raw Materials and Devices

  • Regulatory

  • Drug Substance/Drug Product

  • Preclinical

  • Clinical Trials

  • Steering Committee

    Kapil Bharti, Co-Chair
    National Institutes of Health, USA​

    Jacqueline Barry, Co-Chair
    Cell and Gene Therapy Catapult, UK​

    Ricardo Baptista
    SmartCella, Sweden​

    Melissa Carpenter
    Carpenter Consulting, USA​

    Derek Hei
    Kenai Therapeutics, USA​

    Ana Hidalgo-Simon
    Leiden University Medical Center, Netherlands

    Deborah Hursh
    Hursh Cell Therapy Consulting, LLC, USA

    Jung-Hyun Kim
    Ajou University, Korea ​

    Tenneille Ludwig
    WiCell Research Institute, USA​

    Hideyuki Okano
    Keio University School of Medicine​

    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, USA

    Working Groups

    Starting Materials

    Kapil Bharti, NIH, USA (Co-chair)​

    Tenneille Ludwig, WiCell, USA (co-chair)​

    Jacqueline Barry, Cell and Gene Therapy Catapult, UK​

    Catharina Brandsten, Takara, USA​

    Elizabeth Csaszar, Notch Therapeutics, Canada​

    Indumathi Mariappan, LV Prasad Eye Institute, India​

    Mark Tomishima, Blue Rock Therapeutics, USA​

    Alex Zhang, Zephyrm, China​

    Banking

    Working Group Members:​

    Jung-Hyun Kim (co-chair), Ajou University, Korea​

    Glyn Stacey (co-chair), ISCBI, UK​

    Elsa Abranches, AstraZeneca, Sweden​

    Ricardo Baptista, SmartCella, Sweden​

    Jie Hao, National Stem Cell Resource Center, China​

    Hyunyoung Kim, KNIH, Korea​

    Tenneille Ludwig. WiCell, USA​

    Joanne Mountford, SNBTS, UK​

    Ancillary Raw Materials & Devices

     Working Group Members:​

    Ricardo Baptista (co-chair), SmartCella, Sweden​

    Uma Lakshmipathy (co-chair), Thermo Fisher, USA​

    Elsa Abranches, AstraZeneca, Sweden​

    Kevin Bruce, Roslin, UK​

    Tamar Harel-Adar, MatriCelf, Israel​

    Annaelie Persson, AstraZeneca, Sweden​

    Anat Shnaiderman, MatriCelf, Israel​

    Shuyan Wang, Zephrym, China​

    Claudia Zylberberg, Akron Bio, USA​

    Regulatory

    Working Group Members:​

    Jacqueline Barry (co-chair), Cell and Gene Therapy Catapult, UK​

    Deborah Hursh (co-chair), Hursh Cell Therapy Consulting, LLC, USA

    Michela Gabaldo, Evotec, Italy​

    Ana Hidalgo-Simon, Leiden University Medical Center, Netherlands

    Killian Kelly, Cynata, Australia​

    John Rasko, Royal Prince Alfred Hospital, Australia​

    Yoji Sato, National Institute of Health Sciences, Japan

    Somya Viswanathan, UHN, Canada

    Drug Substance/Drug Product

    Working Group Members:​

    Derek Hei (co-chair), Kenai Therapeutics, USA​

    Jennifer Hollands (co-chair), Cell Therapies Pty Ltd, Australia​

    Ricardo Baptista, SmartCella, Sweden​

    Melissa Carpenter, Carpenter Consulting, USA​

    Jennifer Dashnau, Century Therapeutics, USA​

    Kate Fynes, eXmoor pharma, UK​

    Mashiro Kino-Oka, University of Osaka, Japan​

    Dhruv Sareen, Cedars-Sinai Medical Center, USA​

    Preclinical

    Working Group Members:​

    Jeanne Loring (co-chair), Aspen Neuroscience, USA​

    Yoji Sato (co-chair), National Institute of Health Sciences, Japan

    Joy Cavagnaro, Access Bio, USA​

    Lila Collins, CIRM, USA​

    Shawna Jackman, Charles River, USA​

    Cristelle Monville, I-Stem, France​

    Andras Nagy, LTRI, Sinai Health, Canada​

    Clive Svendsen, Cedars Sinai, USA​

    Consultant: Michaela Sharpe, Moare Solutions, UK​

    ​ Clinical Trials

    Working Group Members:​

    Claire Henchcliffe (co-chair), University of California, Irvine, USA​

    John Rasko (co-chair), Royal Prince Alfred Hospital, Australia​

    Stanley Lazic, Prioris.ai Inc​

    Hideyuki Okano, Keio University, Japan​

    Alan Trounson, Catherics and Monash University, Australia​

    Graziella Pellegrini, University of Modena and Reggio Emilia Modena​

    Somya Viswanathan, UHN, Canada​

    Kirsty Wydenbach, ex-MHRA Consultant, UK​

    Consultant: Roger Barker, University of Cambridge, UK​

Setting the Standards for Human Stem Cell Research Podcast

Basic Research Standards Release Presentation

Highlights the release of the Standards, covering the scope and design of the initiative, lessons learned, and reporting requirements proposed. This session was recorded at the ISSCR Annual meeting in June, 2023.

The ISSCR Standards Initiative is made possible through contributions by: