Human stem cell-based embryo models: innovation, ethics, and policy

The aim of this White Paper is to establish a foundational framework for research, technological development, and regulation in the emerging field of stem cell-based embryo models (SCBEMs). These models, generated from Pluripotent Stem Cells, are designed to recapitulate essential events in early stages of human development. They have the potential to illuminate the early stages of embryo development and implantation and hold promise as an avenue to address global health challenges, including infertility and pregnancy loss, congenital, neonatal and adult conditions, and the need for organ transplants. While SCBEMs are not a substitute for human embryos, their tractability for large-scale analysis and their abilities to model the earliest stages of embryonic development suggest that they will have a significant impact on reproductive biology and regenerative medicine. But SCBEMs do not just raise novel scientific questions; they pose ethical and legal questions that need to be addressed. The paper stems from a meeting of a core group of researchers that met at the Institut Pasteur in Paris in November 2024 and represents the views of an extended group that has worked to elaborate the documents as a consensus for the field. Here, we provide a framework to guide research in this new field. We do this by summarizing the state of the science, assessing current SCBEM research in relation to its primary future applications and addressing the need for continued ethical and regulatory oversight associated with this new field.

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Publication Details

Journal
Human Reproduction
Published
2026-03-24
DOI
https://doi.org/10.1093/humrep/deag035
Primary Topic
Pluripotent Stem Cells Research
Type
article
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article

Human stem cell-based embryo models: innovation, ethics, and policy

Human Reproduction
Pluripotent Stem Cells Research
article

Human stem cell-based embryo models: innovation, ethics, and policy

article en

Abstract

The aim of this White Paper is to establish a foundational framework for research, technological development, and regulation in the emerging field of stem cell-based embryo models (SCBEMs). These models, generated from Pluripotent Stem Cells, are designed to recapitulate essential events in early stages of human development. They have the potential to illuminate the early stages of embryo development and implantation and hold promise as an avenue to address global health challenges, including infertility and pregnancy loss, congenital, neonatal and adult conditions, and the need for organ transplants. While SCBEMs are not a substitute for human embryos, their tractability for large-scale analysis and their abilities to model the earliest stages of embryonic development suggest that they will have a significant impact on reproductive biology and regenerative medicine. But SCBEMs do not just raise novel scientific questions; they pose ethical and legal questions that need to be addressed. The paper stems from a meeting of a core group of researchers that met at the Institut Pasteur in Paris in November 2024 and represents the views of an extended group that has worked to elaborate the documents as a consensus for the field. Here, we provide a framework to guide research in this new field. We do this by summarizing the state of the science, assessing current SCBEM research in relation to its primary future applications and addressing the need for continued ethical and regulatory oversight associated with this new field.

Human Reproduction
BGI Group (China) (CN), Institució Catalana de Recerca i Estudis Avançats (ES), Institute of Molecular Biotechnology (AT), Brigham and Women's Hospital (US), Cincinnati Children's Hospital Medical Center (US), Centre National de la Recherche Scientifique (FR), Babraham Institute (GB), Karolinska University Hospital (SE), Vrije Universiteit Brussel (BE), Harvard University (US), Jawaharlal Nehru Centre for Advanced Scientific Research (IN), Inserm (FR), Institut Pasteur (FR), The University of Melbourne (AU), Durham University (GB), Chinese Academy of Sciences (CN), Washington University in St. Louis (US), Université Paris Cité (FR), Kyoto University (JP), Rega Institute for Medical Research (BE), University of Cambridge (GB), Université Paris Sciences et Lettres (FR), University of Michigan (US), Leiden University Medical Center (NL), The Francis Crick Institute (GB), Novo Nordisk Foundation (DK), Hospital for Sick Children (CA), Gairdner Foundation (CA), Centre Hospitalier Universitaire de Nantes (FR), Fahd bin Sultan University (SA), Institute for Stem Cell Biology and Regenerative Medicine (IN), Massachusetts General Hospital (US), Cambridge School (PT), Guangzhou Experimental Station (CN), Bridge University (SS), University Hospital of Zurich (CH), American Committee for the Weizmann Institute of Science (US), Friedrich Miescher Institute (CH), Primate Conservation (US), Guangzhou Regenerative Medicine and Health Guangdong Laboratory (CN), Jackson Laboratory (US), Centre d'Investigation Clinique de Nantes (FR), Stem Cell Institute (PA), Institute of Genetics and Biophysics (IT), Centre Hospitalier de l’Université de Montréal (CA), Vienna Biocenter (AT), Kyoto University Hospital (JP), Murdoch Children's Research Institute (AU), Harvard Stem Cell Institute (US), University of Chinese Academy of Sciences (CN), Institute of Zoology (CN), Weizmann Institute of Science (IL), Université de Montréal (CA), University of Otago (NZ), The University of Texas at Austin (US), The University of Texas Southwestern Medical Center (US), Nantes Université (FR)
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