In recent years there have been notable key developments in stem cell research as well as a rapid progress in several areas of human embryo-related research such as the technologies for extended in vitro culture of human embryos. To respond to these advances in science, the ISSCR Guidelines, which were last adapted in 2016, have been revised by an international task force of about 50 experts from 14 countries (scientists, clinicians, ethicists, lawyers, and policy specialists). The changes include recommendations for using human embryo models, lab-derived gametes, and human-animal chimeras as well as proposing a modification of the widely accepted two-week maximum for growing human embryos in culture. Even though the guidelines themselves are only recommendations and not legally binding, they serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. Furthermore, they provide a basis for regulatory frameworks in countries without existing regulatory authorities.
The revised guidelines and particularly the suggestion to loosen the 14-day limit for culturing human embryos in favor of considering to determine at which point experiments must be discontinued on a case by case basis for studies proposing to grow human embryos were met with a diverse response in the international press.
The 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation are available free of charge. You can download your copy here. A German translation is in progress as a joint project of the GSCN and the Stem Cell Network.NRW and expected to be available by the end of the year.
For more detailed information, please refer to the following accompanying articles:
ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update, Lovell-Badge et al., 2021 Stem Cell, Reports, JUNE 08
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