Academic Journal
Human Stem Cell-Based Embryo Model Research: Ethics and Regulations.
| Τίτλος: | Human Stem Cell-Based Embryo Model Research: Ethics and Regulations. |
|---|---|
| Συγγραφείς: | Kobayashi C; Uehiro Division for Applied Ethics, Graduate School of Humanities and Social Sciences, Hiroshima University, Higashihiroshima, Japan., Ishida S; Uehiro Division for Applied Ethics, Graduate School of Humanities and Social Sciences, Hiroshima University, Higashihiroshima, Japan., Sawai T; Uehiro Division for Applied Ethics, Graduate School of Humanities and Social Sciences, Hiroshima University, Higashihiroshima, Japan. tstmsw@hiroshima-u.ac.jp.; Graduate School of Humanities and Social Sciences, Hiroshima University, Higashihiroshima, Japan. tstmsw@hiroshima-u.ac.jp.; Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. tstmsw@hiroshima-u.ac.jp. |
| Πηγή: | Methods in molecular biology (Clifton, N.J.) [Methods Mol Biol] 2026; Vol. 3048, pp. 1-16. |
| Τύπος έκδοσης: | Journal Article; Review |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Humana Press Country of Publication: United States NLM ID: 9214969 Publication Model: Print Cited Medium: Internet ISSN: 1940-6029 (Electronic) Linking ISSN: 10643745 NLM ISO Abbreviation: Methods Mol Biol Subsets: MEDLINE |
| Imprint Name(s): | Publication: Totowa, NJ : Humana Press Original Publication: Clifton, N.J. : Humana Press |
| Ιατρικοί όροι (MeSH): | Embryo Research*/ethics , Embryo Research*/legislation & jurisprudence , Stem Cell Research*/ethics , Stem Cell Research*/legislation & jurisprudence , Human Embryonic Stem Cells*/cytology, Humans |
| Περίληψη: | Given rapid advances in the life sciences, stem cell-based embryo models (SCBEMs) call for careful ethical and regulatory consideration. As with similar research related to human embryos and reproduction, SCBEMs raise important normative questions. In this chapter, we survey these questions, outline possible answers, and discuss their implications for global regulatory development. We also map major ethical issues related to SCBEM research, identify areas in need of further debate, and examine the governance frameworks required for responsible progress. We conclude with recommendations to guide SCBEM research so that it advances scientific innovation while protecting the public interest. In particular, we highlight the importance of careful planning, transparent communication, inclusive dialogue, robust governance, and ongoing empirical inquiry. Taken together, these measures can help ensure that SCBEM research proceeds responsibly, remains ethically sound, and earns public trust. (© 2025. Springer Science+Business Media, LLC.) |
| References: | Van den Brink SC, Baillie-Johnson P, Balayo T et al (2014) Symmetry breaking, germ layer specification and axial organisation in aggregates of mouse embryonic stem cells. Development 141(22):4231–4242. https://doi.org/10.1242/dev.113001. (PMID: 10.1242/dev.113001253713604302915) Warmflash A, Sorre B, Etoc F et al (2014) A method to recapitulate early embryonic spatial patterning in human embryonic stem cells. Nat Methods 11(8):847–854. https://doi.org/10.1038/nmeth.3016. (PMID: 10.1038/nmeth.3016249739484341966) Baillie-Benson P, Moris N, Martinez Arias A (2020) Pluripotent stem cell models of early mammalian development. Curr Opin Cell Bio 66(1):89–96. https://doi.org/10.1016/j.ceb.2020.05.010. (PMID: 10.1016/j.ceb.2020.05.010) Matthews KRW, Wagner DS, Warmflash A (2021) Stem cell-based models of embryos: the need for improved naming conventions. Stem Cell Rep 16(5):1014–1020. https://doi.org/10.1016/j.stemcr.2021.02.018. (PMID: 10.1016/j.stemcr.2021.02.018) International Society for Stem Cell Research (2021) Guidelines for stem cell research and clinical translation. International Society for Stem Cell Research (ISSCR). https://www.isscr.org/guidelines . Accessed 10 Aug 2025. Matthews KRW, Moralí D (2020) National human embryo and embryoid research policies: a survey of 22 top research-intensive countries. Regen Med 15(7):1905–1917. https://doi.org/10.2217/rme-2019-0138. (PMID: 10.2217/rme-2019-013832799737) Nicolas P, Etoc F, Brivanlou AH (2021) The ethics of human-embryoids model: a call for consistency. J Mol Med 99(4):569–579. https://doi.org/10.1007/s00109-021-02053-7. (PMID: 10.1007/s00109-021-02053-7337927558026457) Brivanlou AH, Rivron N, Gleicher N (2021) How will our understanding of human development evolve over the next 10 years? Nat Commun 12(1):4614. https://doi.org/10.1038/s41467-021-24794-2. (PMID: 10.1038/s41467-021-24794-2343263278322086) Clark AT, Brivanlou A, Fu J et al (2021) Human embryo research, stem cell-derived embryo models and in vitro gametogenesis: considerations leading to the revised ISSCR guidelines. Stem Cell Rep 16(6):1416–1424. https://doi.org/10.1016/j.stemcr.2021.05.008. (PMID: 10.1016/j.stemcr.2021.05.008) Landecker HL, Clark AT (2023) Human embryo models made from pluripotent stem cells are not synthetic; they aren’t embryos, either. Cell Stem Cell 30(10):1290–1293. https://doi.org/10.1016/j.stem.2023.09.006. (PMID: 10.1016/j.stem.2023.09.0063780203410927377) Monasterio Astobiza A, Molina Pérez A (2022) Why iblastoids (embryo-like structures) do not raise significant ethical issues. Am J Bioeth 22(1):59–61. https://doi.org/10.1080/15265161.2021.2001103. (PMID: 10.1080/15265161.2021.200110334962199) Nuffield Council on Bioethics (2024) Stem cell-based embryo models: a review of ethical and governance questions. https://www.nuffieldbioethics.org/publication/human-stem-cell-based-embryo-models-a-review-of-ethical-and-governance-questions/ . Accessed 10 Aug 2025. Barnhart AJ, Dierickx K (2022) The many moral matters of organoid models: a systematic review of reasons. Med Health Care Philos 25(3):545–560. https://doi.org/10.1007/s11019-022-10082-3. (PMID: 10.1007/s11019-022-10082-335532849) Warren MA (1997) Moral status: obligations to persons and other living things. Oxford University Press, Oxford. Iltis AS, Koster G, Reeves E et al (2023) Ethical, legal, regulatory, and policy issues concerning embryoids: a systematic review of the literature. Stem Cell Res Ther 14(1):209. https://doi.org/10.1186/s13287-023-03448-8. (PMID: 10.1186/s13287-023-03448-83760521010441753) Aach J, Lunshof J, Iyer E et al (2017) Addressing the ethical issues raised by synthetic human entities with embryo-like features. eLife 6:e20674. https://doi.org/10.7554/eLife.20674. (PMID: 10.7554/eLife.20674284948565360441) McCully S (2021) The time has come to extend the 14-day limit. J Med Ethics 47(12):e66–e66. https://doi.org/10.1136/medethics-2020-106406. (PMID: 10.1136/medethics-2020-106406) Sawai T, Minakawa T, Pugh J et al (2020) The moral status of human embryo-like structures: potentiality matters? EMBO Rep 21(8):e50984. https://doi.org/10.15252/embr.202050984. (PMID: 10.15252/embr.202050984327155437403716) Stier M, Schoene-Seifert B (2013) The argument from potentiality in the embryo protection debate: finally “depotentialized”? Am J Bioeth 13(1):19–27. https://doi.org/10.1080/15265161.2012.743619. (PMID: 10.1080/15265161.2012.74361923311835) Bortolotti L, Harris J (2006) Embryos and eagles: symbolic value in research and reproduction. Camb Q Healthc Ethics 15(1):22–34. https://doi.org/10.1017/S0963180106060038. (PMID: 10.1017/S096318010606003816529304) Pereira Daoud AM, Popovic M et al (2020) Modelling human embryogenesis: embryo-like structures spark ethical and policy debate. Hum Reprod Update 26(6):779–798. https://doi.org/10.1093/humupd/dmaa027. (PMID: 10.1093/humupd/dmaa02732712668) Neaves W (2017) The status of the human embryo in various religions. Development 144(14):2541–2543. https://doi.org/10.1242/dev.151886. (PMID: 10.1242/dev.15188628720650) Munsie M, Hyun I, Sugarman J (2017) Ethical issues in human organoid and gastruloid research. Development 144(6):942–945. https://doi.org/10.1242/dev.140111. (PMID: 10.1242/dev.14011128292838) Mittleman B (2024) Rethinking general consent for stem cell-based embryo model research. Stan J CR & CL 20(1):181–218. https://doi.org/10.1234/sjcrcl.2024.20.1.181. (PMID: 10.1234/sjcrcl.2024.20.1.181) Kataoka M, Gyngell C, Savulescu J et al (2024) The donation of human biological material for brain organoid research: the problems of consciousness and consent. Sci Eng Ethics 30(1):3. https://doi.org/10.1007/s11948-024-00471-7. (PMID: 10.1007/s11948-024-00471-73831525710844458) Wei Y, Zhang C, Fan G et al (2021) Organoids as novel models for embryo implantation study. Reprod Sci 28(6):1637–1643. https://doi.org/10.1007/s43032-021-00501-w. (PMID: 10.1007/s43032-021-00501-w33650092) De Groot H, van Daal M, Hofland RW et al (2025) The ethics and economics of organoid commercialization: potential donors’ perspectives. BMC Med Ethics 26(1):109. https://doi.org/10.1186/s12910-025-01269-3. (PMID: 10.1186/s12910-025-01269-34073099812309163) Paşca SP, Arlotta P, Bateup HS et al (2022) A nomenclature consensus for nervous system organoids and assembloids. Nature 609(7929):7929. https://doi.org/10.1038/s41586-022-05219-6. (PMID: 10.1038/s41586-022-05219-6) M’hamdi HI (2025) Language and labels from the lab: definitions in the stem cell-based embryo model debate. Stem Cell Rep 20(5):102477. https://doi.org/10.1016/j.stemcr.2025.102477. (PMID: 10.1016/j.stemcr.2025.102477) Cambridge Reproduction (2024) Code of practice for the generation and use of human stem cell-based embryo models. Cambridge Reproduction. https://www.repro.cam.ac.uk/scbemcode . Accessed 10 Aug 2025. United Nations (2005) United Nations Declaration on Human Cloning, Pub. L. No. A/C.6/59/L.27/Add.1. https://digitallibrary.un.org/record/541409 . Accessed 10 Aug 2025. Asplund K (2020) Use of in vitro fertilization: ethical issues. Upsala J Med Sci 125(2):192–199. https://doi.org/10.1080/03009734.2019.1684405. (PMID: 10.1080/03009734.2019.168440531686575) Alon I, Cassou M, Golan OC et al (2024) Mapping ethical, legal, and social implications (ELSI) of gamete donation. J Assist Reprod Genet 41(11):2855–2875. https://doi.org/10.1007/s10815-024-03229-z. (PMID: 10.1007/s10815-024-03229-z3918322411621250) Writing Group on behalf of the ESHRE Ethics Committee, Shenfield F, Tarlatzis B et al (2025) Ethical considerations on surrogacy. Hum Reprod 40(3):420–425. https://doi.org/10.1093/humrep/deaf006. (PMID: 10.1093/humrep/deaf006) Swierstra T, Stemerding D, Boenink M (2009) Exploring techno-moral change: the case of the obesity pill. In: Sollie P, Düwell M (eds) Evaluating new technologies: methodological problems for the ethical assessment of technology developments. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-2229-5_9. (PMID: 10.1007/978-90-481-2229-5_9) Nickel PJ, Kudina O, van de Poel I (2022) Moral uncertainty in technomoral change: bridging the explanatory gap. Perspect Sci 30(2):260–283. https://doi.org/10.1162/posc_a_00414. (PMID: 10.1162/posc_a_00414) Danaher J, Sætra HS (2023) Mechanisms of techno-moral change: a taxonomy and overview. Ethical Theory Moral Pract 26(5):763–784. https://doi.org/10.1007/s10677-023-10397-x. (PMID: 10.1007/s10677-023-10397-x) Hopster JKG, Arora C, Blunden C et al (2022) Pistols, pills, pork and ploughs: the structure of technomoral revolutions. Inquiry 68(2):264–296. https://doi.org/10.1080/0020174X.2022.2090434. (PMID: 10.1080/0020174X.2022.2090434) Stilgoe J, Owen R, Macnaghten P (2013) Developing a framework for responsible innovation. Res Policy 42(9):1568–1580. https://doi.org/10.1016/j.respol.2013.05.008. (PMID: 10.1016/j.respol.2013.05.008) Sawai T, Ishida S, Kobayashi C et al (2025) Regulating stem cell–based embryo model research in Japan. EMBO Rep 26(7):1682–1687. https://doi.org/10.1038/s44319-025-00409-5. (PMID: 10.1038/s44319-025-00409-54008747011977183) Akabayashi A (2020) Bioethics across the globe: rebirthing bioethics. Asian Bioeth Rev 12(2):99–113. https://doi.org/10.1007/s41649-020-00113-3. (PMID: 10.1007/s41649-020-00113-3) Rivron NC, Arias AM, Pera MF et al (2023) An ethical framework for human embryology with embryo models. Cell 186(17):3548–3557. https://doi.org/10.1016/j.cell.2023.07.028. (PMID: 10.1016/j.cell.2023.07.02837595564) De Miguel Beriain I, Rueda J, Villalba A (2024) Re-defining the human embryo. EMBO Rep 25(2):467–470. https://doi.org/10.1038/s44319-023-00034-0. (PMID: 10.1038/s44319-023-00034-03817791810897213) Sharma-Wallace L, Velarde SJ, Wreford A (2018) Adaptive governance good practice: show me the evidence! J Environ Manag 222:174–184. https://doi.org/10.1016/j.jenvman.2018.05.067. (PMID: 10.1016/j.jenvman.2018.05.067) |
| Contributed Indexing: | Keywords: Embryonic stem cells; Human reproduction; Induced pluripotent stem cells; Informed consent; Moral Status; Public trust; Responsible science; Stem cell research; Stem cell–based embryo models; Techno-moral change |
| Entry Date(s): | Date Created: 20251003 Date Completed: 20260804 Latest Revision: 20260820 |
| Update Code: | 20260821 |
| DOI: | 10.1007/7651_2025_668 |
| PMID: | 41042296 |
| Βάση Δεδομένων: | MEDLINE |
καταχωρήστε σχόλιο πρώτοι!