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

Supported by ISSCR Staff

  • Tyler Lamb, Director of Policy

  • Jack Mosher, Scientific Advisor

  • Co-Chair - Tenneille Ludwig, PhD
    WiCell Research Institute, USA

    Co-Chair - Peter Andrews, DPhil
    The University of Sheffield, UK

    Ivana Barbaric, DPhil
    The University of Sheffield, UK

    Nissim Benvenisty, PhD
    Hebrew University, Israel

    Madeline Lancaster, PhD
    MRC Laboratory of Molecular Biology, UK

    Christine Mummery, PhD
    Leiden University Medical Center, Netherlands

    Martin Pera, PhD
    The Jackson Laboratory, USA

    Yoji Sato, PhD
    National Institute of Health Sciences, Japan

    Glyn Stacey, PhD
    International Stem Cell Banking Initiative, UK

    Christine A. Wells, DPhil
    University of Melbourne, Australia

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

  • Co-Chair - Glyn Stacey, PhD
    International Stem Cell Banking Initiative, UK

    Co-Chair - Tenneille Ludwig. PhD
    WiCell Research Institute, USA

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

    Laurence Daheron, PhD
    Harvard Stem Cell Institute, USA

    Jon Draper, PhD
    Stem Cell Network, Canada

    Lyn Healy, PhD
    Francis Crick Institute, UK

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

  • Co-Chair - Peter Andrews, DPhil
    The University of Sheffield, UK

    Co-Chair - Martin Pera, PhD
    The Jackson Laboratory, USA

    Lyn Healy, PhD
    Francis Crick Institute, UK

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

    Tenneille Ludwig, PhD
    WiCell Research Institute, USA

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

    Austin Smith, PhD
    University of Exeter, UK

  • Co-Chair - Ivana Barbaric, DPhil
    The University of Sheffield, UK

    Tenneille Ludwig, PhD
    WiCell Research Institute, USA

    Peter Andrews, DPhil
    The University of Sheffield, UK

    Nissim Benvenisty, PhD
    Hebrew University, Israel

    Martin Pera, PhD
    The Jackson Laboratory, USA

    Yoji Sato, PhD
    National Institute of Health Sciences, Japan

    Claudia Spits, PhD
    Vrije Universiteit Brussel, Belgium

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

  • Co-Chair - Madeline Lancaster, PhD
    MRC Laboratory of Molecular Biology, UK

    Co-Chair - Christine Mummery, PhD
    Leiden University Medical Center, Netherlands

    Anita Bhattacharyya, PhD
    University of Wisconsin-Madison, USA

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

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

    Kim Jensen, PhD
    Novo Nordisk Foundation Center for Stem Cell Medicine, University of Copenhagen, Denmark

    Prisca Liberali, PhD
    Friedrich Miescher Institute for Biomedical Research, Switzerland

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

    Jihwan Song, DPhil
    CHA University, and iPS Bio, Inc., Korea

    Christine A. Wells, PhD
    University of Melbourne, Australia

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

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

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

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

    Ricardo Baptista, PhD
    SmartCella, Sweden​

    Melissa Carpenter, PhD
    Carpenter Consulting, USA​

    Derek Hei, PhD
    Kenai Therapeutics, USA​

    Ana Hidalgo-Simon, PhD
    Leiden University Medical Center, Netherlands

    Deborah Hursh, PhD
    Hursh Cell Therapy Consulting, LLC, USA

    Jung-Hyun Kim, PhD
    Ajou University, Korea ​

    Tenneille Ludwig, PhD
    WiCell Research Institute, USA​

    Hideyuki Okano, MD, PhD
    Keio University School of Medicine​

    John Rasko, PhD
    Royal Prince Alfred Hospital, Australia​

    Yoji Sato, PhD
    National Institute of Health Sciences, Japan​

    Glyn Stacey, PhD
    International Stem Cell Banking Initiative, UK​

    Clive Svendsen, PhD
    Cedars Sinai Regenerative Medicine Institute, USA

  • Co-Chair - Kapil Bharti, PhD
    National Institutes of Health, USA

    Co-Chair - Tenneille Ludwig, PhD
    WiCell Research Institute, USA

    Jacqueline Barry, PhD
    Cell and Gene Therapy Catapult, UK​

    Catharina Brandsten, DMsc
    Takara, USA​

    Elizabeth Csaszar, PhD
    Notch Therapeutics, Canada​

    Indumathi Mariappan, PhD
    LV Prasad Eye Institute, India​

    Mark Tomishima, PhD
    Blue Rock Therapeutics, USA​

    Alex Zhang, PhD
    Zephyrm, China​

  • Co-Chair - Jung-Hyun Kim, PhD
    Ajou University, Korea​

    Co-Chair - Glyn Stacey, PhD
    International Stem Cell Banking Initiative, UK​

    Elsa Abranches, PhD
    AstraZeneca, Sweden​

    Ricardo Baptista, PhD
    SmartCella, Sweden​

    Jie Hao, PhD
    National Stem Cell Resource Center, China​

    Hyunyoung Kim, PhD
    KNIH, Korea​

    Tenneille Ludwig, PhD
    WiCell Research Institute, USA​

    Joanne Mountford, PhD
    SNBTS, UK​

  • Co-Chair - Ricardo Baptista, PhD
    SmartCella, Sweden​

    Co-Chair - Uma Lakshmipathy, PhD
    Thermo Fisher, USA​

    Elsa Abranches, PhD
    AstraZeneca, Sweden​

    Kevin Bruce
    Roslin, UK​

    Tamar Harel-Adar, PhD
    MatriCelf, Israel​

    Annaelie Persson, MS
    AstraZeneca, Sweden​

    Anat Shnaiderman, MS
    MatriCelf, Israel​

    Shuyan Wang, PhD
    Zephrym, China​

    Claudia Zylberberg, PhD
    Akron Bio, USA​

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

    Co-Chair - Deborah Hursh, PhD
    Hursh Cell Therapy Consulting, LLC, USA

    Michela Gabaldo, Evotec, MSc
    Italy​

    Ana Hidalgo-Simon, PhD
    Leiden University Medical Center, Netherlands

    Killian Kelly, PhD
    Cynata, Australia​

    John Rasko, PhD
    Royal Prince Alfred Hospital, Australia​

    Yoji Sato, PhD
    National Institute of Health Sciences, Japan

    Somya Viswanathan, PhD
    UHN, Canada

  • Co-Chair -Derek Hei, PhD
    Kenai Therapeutics, USA​

    Co-Chair - Jennifer Hollands, PhD
    Cell Therapies Pty Ltd, Australia​

    Ricardo Baptista, PhD
    SmartCella, Sweden​

    Melissa Carpenter, PhD
    Carpenter Consulting, USA​

    Jennifer Dashnau, PhD
    Century Therapeutics, USA​

    Kate Fynes, PhD
    eXmoor pharma, UK​

    Mashiro Kino-Oka, PhD
    University of Osaka, Japan​

    Dhruv Sareen, PhD
    Cedars-Sinai Medical Center, USA​

  • Co-Chair - Jeanne Loring, PhD
    Aspen Neuroscience, USA​

    Co-Chair - Yoji Sato, PhD
    National Institute of Health Sciences, Japan

    Joy Cavagnaro, PhD
    Access Bio, USA​

    Lila Collins, PhD
    CIRM, USA​

    Shawna Jackman, PhD
    Charles River, USA​

    Christelle Monville, PhD
    I-Stem, France​

    Andras Nagy, PhD
    LTRI, Sinai Health, Canada​

    Clive Svendsen, PhD
    Cedars Sinai, USA​

    Consultant: Michaela Sharpe, PhD
    Moare Solutions, UK​

  • Co-Chair - Claire Henchcliffe, MD, DPhil
    University of California, Irvine, USA​

    Co-Chair - John Rasko, PhD
    Royal Prince Alfred Hospital, Australia​

    Stanley Lazic, MPhil
    Prioris.ai Inc​

    Hideyuki Okano, MD, PhD
    Keio University, Japan​

    Alan Trounson, PhD
    Catherics and Monash University, Australia​

    Graziella Pellegrini, PhD
    University of Modena and Reggio Emilia Modena​

    Somya Viswanathan, PhD
    UHN, Canada​

    Kirsty Wydenbach, MS
    ex-MHRA Consultant, UK​

    Consultant: Roger Barker, PhD
    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: