Update 2025: In 2025, the ISSCR Guidelines for Stem Cell Research and Clinical Translation 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.
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 all 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.
Find the 2025 Update of the ISSCR Guidelines for Stem Cell Research and Clinical Translation here.
NEW: Translation of the ISSCR Guidelines for Stem Cell Research and Clinical TranslationWhite Paper
The 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation are available here. The German translation is available here.
The translation was a joint project of the GSCN (Daniel Besser, Stefanie Mahler) , Ole Pless (ITMP Fraunhofer) and the Stem Cell Network.NRW (Sira Groscurth) and Hannah Schickl (BIH /Charité).
For more detailed information about the update of the ISSCR Guidelines in 2021, take a look at these articles:
Ethics - New guidelines bring current developments in stem cell research into focus. An interview with Hans Schöler, Sara Gerke and Tobias Cantz, GSCN Annual Magazine, 2021/22
ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update, Lovell-Badge et al., 2021 Stem Cell, Reports, JUNE 08 2021
Human embryo research, stem cell-derived embryo models and in vitro gametogenesis: Considerations leading to the revised ISSCR guidelines, Clark et al. 2021 Stem Cell, Reports, JUNE 08
ISSCR guidelines for the transfer of human pluripotent stem cells and their direct derivatives into animal hosts, Hyun et al., 2021 Stem Cell, Reports, JUNE 08
ISSCR’s Guidelines for Stem Cell Research and Clinical Translation: Supporting development of safe and efficacious stem cell-based interventions, Turner, 2021 Stem Cell, Reports, JUNE 08