ISSCR updates guidelines for oversight and regulation of stem cell-based embryo models

The International Society for Stem Cell Research (ISSCR) Embryo Models Working Group has released updated recommendations for the oversight and regulation of stem cell-based embryo models (SCBEM), aiming to address rapid advancements and ensure responsible scientific progress. The proposed recommendations are detailed in a new paper published today in Stem Cell Reports.

SCBEMs are three dimensional structures that replicate key aspects of early embryonic development, offering unprecedented potential to enhance our understanding of human developmental biology and reproductive science.

Stem cell-based embryo models are poised to revolutionize our understanding of early human development and improve clinical practices in assisted reproduction. However, as these models advance, it is crucial that they are studied in a framework that balances scientific progress with ethical, legal, and social considerations. These proposed recommendations are designed to foster innovation while at the same time providing regulatory guidance for key stakeholders in this vital area of biomedical research."

Amander Clark, University of California, Los Angeles, USA, co-chair of the ISSCR Embryo Models Working Group and an expert in human stem cell and reproductive science

Janet Rossant, CC, PhD, world-renowned expert in developmental biology and co-chair of the ISSCR Embryo Models Working Group stated, "Given the acceleration of these technologies, it was important to convene a working group to evaluate whether the existing ISSCR Guidelines should be amended to keep pace with new advances."

The recommendations outlined in the paper, Stem cell-based embryo models: the 2021 ISSCR stem cell guidelines revisited, address recent scientific breakthroughs that enable the creation of increasingly complex models efficiently and without reliance on major extraembryonic lineages. The group made three central recommendations:

1. All research involving three-dimensional SCBEMs should undergo appropriate
   review,
2. Research must have a clear scientific rationale, and
3. Research should be subject to defined timelines.

The paper also recommends the removal of the distinction between integrated and non-integrated models. These modifications aim to bring clarity to the emerging field, guide the deliberations of researchers, oversight committees, and stakeholders, and ensure the continued confidence of the public in the responsible advancement of SCBEM research.

The co-chairs will present the proposed recommendations in June to the ISSCR Board of Directors as part of a targeted update to the 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation.