The International Society for Stem Cell Research (ISSCR) has released an updated version of its 2021 Guidelines for Stem Cell Research and Clinical Translation, focusing on the development and application of human stem cell-based embryo models (SCBEMs). This update addresses significant advancements in the field and incorporates recommendations from a white paper by the ISSCR Embryo Models Working Group, published in June.
SCBEMs are three-dimensional structures derived from stem cells that replicate key aspects of early embryonic development. These innovative models hold immense potential to enhance our understanding of human developmental biology and reproductive science. The ISSCR’s updated guidelines aim to address the ethical and regulatory considerations that accompany these scientific advancements.
Understanding Stem Cell-Based Embryo Models
Stem cell-based embryo models represent a groundbreaking approach to studying early human development. By mimicking the initial stages of embryogenesis, researchers can gain insights into developmental processes that were previously inaccessible. This advancement is crucial for both basic science and the development of new therapeutic strategies.
“This Guidelines update underscores the ISSCR’s steadfast commitment to proactively addressing the ethical and regulatory considerations that accompany scientific advances,” stated ISSCR President Hideyuki Okano.
“Stem cell-based embryo models are transforming how we study early human development, and it is critical that this progress is supported by clear guidance, a strong sense of responsibility, and global consensus.”
Key Revisions in the 2025 Update
The 2025 update to the ISSCR Guidelines includes several key revisions specifically targeting SCBEM technologies. These changes emerged from a focused, deliberative process led by experts Amander Clark from the University of California, Los Angeles, and Janet Rossant from the Hospital for Sick Children in Toronto. The revisions aim to provide updated international guidance for researchers, journal editors, regulators, funders, and the public.
Major Changes in the Guidelines
- Replaces the classification of models as “integrated” or “non-integrated” with the inclusive term “SCBEMs.”
- Proposes that all 3D SCBEMs have a clear scientific rationale, a defined endpoint, and be subject to an appropriate oversight mechanism.
- Reiterates that all SCBEMs are in vitro models and must not be transplanted into the uterus of a living animal or human host.
- Includes a new recommendation prohibiting the ex vivo culture of SCBEMs to the point of potential viability, known as ectogenesis.
The Role of ISSCR in Global Stem Cell Research
The ISSCR has long been recognized as the international benchmark for scientific and ethical rigor in stem cell research. Its guidelines support the development of regulatory frameworks in countries where such systems are still emerging. By adhering to these guidelines, researchers can ensure that their work is conducted with integrity and that new therapies are safe, effective, and evidence-based.
The organization, which boasts nearly 5,000 members from over 80 countries, is dedicated to promoting excellence in stem cell science and its applications to human health. The ISSCR’s mission is to facilitate the translation of stem cell research into clinical practice, ensuring that advances in the field are both scientifically sound and ethically responsible.
Looking Ahead: The Future of Stem Cell Research
The ISSCR’s update represents a proactive approach to the rapidly advancing field of stem cell research. By maintaining an agile, collaborative model, the organization plans to continue addressing evolving areas of research that require updated, globally harmonized oversight standards.
As stem cell-based technologies continue to evolve, the ISSCR’s guidelines will play a crucial role in shaping the future of the field. Researchers, regulators, and the public alike will look to these guidelines for direction, ensuring that scientific progress is matched by ethical responsibility and global consensus.
The ISSCR’s commitment to updating its guidelines in response to new scientific developments underscores the importance of adaptive governance in the ever-changing landscape of biomedical research. As the field progresses, the organization’s leadership will remain vital in guiding the responsible exploration of stem cell science.
