Guidelines for Stem Cell Research and Clinical Translation

August 2025 Update | Version 1.2

  • The ISSCR Guidelines address the international diversity of cultural, political, legal, and ethical issues associated with stem cell research and its translation to medicine. The guidelines maintain and underscore widely shared principles in science that call for rigor, oversight, and transparency in all areas of practice. Adherence to these principles provides assurance that stem cell research is conducted with scientific and ethical integrity and that new therapies are evidence-based.

    The guidelines were originally updated in 2021 to encompass a broader and more expansive scope of research and clinical endeavor while maintaining the fundamental principles of the research and application. The 2021 guidelines included recommendations to address the recent scientific advances involving embryos, stem cell-based embryo models, chimeras, organoids, and genome editing.

    In 2025, the guidelines underwent a targeted update to the section on stem cell–based embryo models. This update refines recommendations in response to scientific and oversight developments in this rapidly evolving area of research. All other sections of the guidelines remain as published in 2021.

    Together, these guidelines promote an ethical, practical, and sustainable approach to stem cell research and the development of cell therapies that can improve human health and be made available to patients in need.

  • The revisions included in the 2025 update to the Guidelines are limited to sections on stem cell-based embryo models (SCBEMs). This focused approach enabled the ISSCR to respond thoughtfully to a defined scientific and oversight need, and to offer updated international guidance for researchers, journal editors, regulators, funders, and the public.

    Key Revisions:

    • Retires the classification of models as "integrated" or "non-integrated" and replaces with the inclusive term “SCBEMs.”

    • Proposes that all 3D SCBEMs have a clear scientific rationale, have a defined endpoint, and be subject to an appropriate oversight mechanism.

    • Reiterates that human SCBEMs are in vitro models and must not be transplanted to the uterus of a living animal or human host.

    • Includes a new recommendation that prohibits the ex vivo culture of SCBEMS to the point of potential viability—so called ectogenesis.

  • Take a look at supporting papers published in Stem Cell Reports and Nature that offer insights from members of the Guidelines Steering Committee. Learn more.

  • Chinese, German, Japanese, Korean, and Spanish translations of the 2021 ISSCR Guidelines are available on the Archives page.

Table of Contents

Download Guideline

ISSCR's Guidelines for Stem Cell Research and Clinical Translation 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.

Additional Resources

Additional context for the 2025 Guidelines update on stem cell-based embryo models:
Stem cell-based embryo models: The 2021 ISSCR stem cell guidelines revisited, by Clark et al, (Stem Cell Reports)

Additional context; papers written by members off the 2021 ISSCR Guidelines Steering Committee:
“Why stem cell guidelines needed an update: New criteria aim to reassure the public to permit progress in contentious research,” by Lovell-Badge (Nature)
“ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 Update,” by Lovell-Badge et al., ISSCR Guidelines Taskforce (Stem Cell Reports)
“Human Embryo Research, Stem Cell-derived Embryo Models and In Vitro Gametogenesis: Considerations Leading to the Revised ISSCR Guidelines,” Clark et al., (Stem Cell Reports)
“ISSCR Guidelines for the Transfer of Human Pluripotent Stem Cells and Their Direct Derivatives into Animal Hosts,” by Hyun et al. (Stem Cell Reports)
“ISSCR’s Guidelines for Stem Cell Research and Clinical Translation: Supporting the Development of Safe and Efficacious Stem Cell-Based Interventions,” by Turner (Stem Cell Reports)
"New Guidelines for Stem Cell and Embryo Research from the ISSCR," by Anthony et al. (Cell Stem Cell)
"ISSCR Guidelines Uphold Human Right to Science for Benefit of All," by Robin Lovell-Badge, Zubin Master, and Bartha Knoppers (Nature)

Visit The Archives for the previous versions of the ISSCR Guidelines for Stem Cell Research and Clinical Translation, as well as their translations.

Steering Committee

  • Shuibing Chen, PhD

    Weill Cornell, USA
    (Co-chair)​

  • Daniela Cornacchia, PhD

    AstraZeneca, Sweden
    (Co-chair)​

  • Luigi Aloia, PhD

    AstraZeneca, UK​

  • Erica Bello, PhD

    Milner Institute, University of Cambridge, UK ​

  • Kapil Bharti, PhD

    NEI/NIH, USA​

  • Hans Clevers, MD, PhD

    Roche, Switzerland ​

  • Magdalena Kasendra, PhD

    Cincinnati Children’s, USA​

  • Henning Kempf, PhD

    GEM CELL hub at Novo Nordisk​

  • Christine Mummery, PhD

    LUMC, Netherlands​

  • Steve Murry, PhD

    Jackson Labs, USA​

  • Hideyuki Okano, MD, PhD

    Keio University, Japan​

  • Li Pang, MD

    FDA, USA​

  • Lee Rubin, PhD

    Harvard University, USA​

  • Charis Segeritz-Walko, PhD

    Novo Nordisk, Denmark ​

  • Clive Svendsen, PhD

    Cedars-Sinai, USA​

  • Carlos Tristan, PhD

    NCATS/NIH, USA​

  • Joseph Wu, MD, PhD

    Stanford University, USA​

  • Matthias Zilbauer, MD, PhD

    University of Cambridge, UK

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.