ISSCR Calls for Enhanced Oversight of Stem Cell Embryo Models

The International Society for Stem Cell Research (ISSCR) has issued updated recommendations for the oversight and regulation of stem cell-based embryo models (SCBEMs), which have gained prominence due to rapid advancements in the field. These guidelines, detailed in a new paper published in Stem Cell Reports on June 11, 2025, aim to ensure responsible scientific progress while addressing the complex ethical, legal, and social implications associated with these models.

SCBEMs are sophisticated three-dimensional structures that replicate significant aspects of early embryonic development, providing researchers with unprecedented insights into human developmental biology and reproductive science. Amander Clark, co-chair of the ISSCR Embryo Models Working Group and a researcher at the University of California, Los Angeles, emphasized the importance of conducting this research within a framework that balances scientific progress with ethical considerations. "Stem cell-based embryo models are poised to revolutionize our understanding of early human development and improve clinical practices in assisted reproduction," Clark stated.

The recommendations come in response to advancements in technology that have enabled the creation of more complex SCBEMs without the need for major extraembryonic lineages. Janet Rossant, a renowned developmental biologist and fellow co-chair of the working group, noted, "Given the acceleration of these technologies, it was crucial to evaluate whether the existing ISSCR Guidelines should be amended to keep pace with new advancements."

The paper outlines three primary recommendations: first, all research involving SCBEMs should be subject to appropriate review; second, research must be backed by a clear scientific rationale; and third, studies should adhere to defined timelines. Furthermore, the group suggests eliminating the distinction between integrated and non-integrated models, which aims to clarify the regulatory landscape for researchers and oversight committees alike.

These modifications are designed to foster innovation while ensuring public confidence in the responsible advancement of SCBEM research. The co-chairs are set to present these proposed recommendations to the ISSCR Board of Directors in June as part of an update to the 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation. The new guidelines will play a pivotal role in shaping future research directions in this rapidly evolving field, with implications for both science and society at large.

As the landscape of stem cell research continues to evolve, the ISSCR's proactive approach underscores the importance of maintaining ethical standards while promoting scientific innovation. The recommendations reflect a growing recognition of the need for robust oversight mechanisms that protect both the integrity of scientific research and the ethical considerations surrounding human development.