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Review
. 2021 Jun 8;16(6):1416-1424.
doi: 10.1016/j.stemcr.2021.05.008. Epub 2021 May 27.

Human embryo research, stem cell-derived embryo models and in vitro gametogenesis: Considerations leading to the revised ISSCR guidelines

Amander T Clark  1 , Ali Brivanlou  2 , Jianping Fu  3 , Kazuto Kato  4 , Debra Mathews  5 , Kathy K Niakan  6 , Nicolas Rivron  7 , Mitinori Saitou  8 , Azim Surani  9 , Fuchou Tang  10 , Janet Rossant  11
Affiliations
Review

Human embryo research, stem cell-derived embryo models and in vitro gametogenesis: Considerations leading to the revised ISSCR guidelines

Amander T Clark et al. Stem Cell Reports. .

Abstract

The ISSCR Guidelines for Stem Cell Research and Clinical Translation were last revised in 2016. Since then, rapid progress has been made in research areas related to in vitro culture of human embryos, creation of stem cell-based embryo models, and in vitro gametogenesis. Therefore, a working group of international experts was convened to review the oversight process and provide an update to the guidelines. This report captures the discussion and summarizes the major recommendations made by this working group, with a specific emphasis on updating the categories of review and engagement with the specialized scientific and ethical oversight process.

Keywords: embryo models; embryo research; gametoogensis; guidelines.

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Conflict of interest statement

Conflicts of interest Amander T. Clark is a board member of the ISSCR and a Scientific Advisory Board member of the Tepper Foundation. Ali Brivanlou is a co-founder or OvaNova Inc., as well as a co-founder of Rumi Scientific Inc. Debra Mathews is a member of the Maryland Stem Cell Research Commission and a paid Academic Collaborator of the National Academy of Medicine's Committee on Emerging Science, Technology, and Innovation in Health and Medicine. Nicolas Rivron is an inventor on two patents describing the blastoid technology (EP2986711 and EP21151455.9). He has received funding from the European Research Council (ERC) under the European Union’s Horizon 2020 Research and Innovation Program ERC-Co grant agreement no. 101002317. Mitinori Saitou is an inventor on patent applications relating to the induction of germ cells from PSCs filed by Kyoto University. Janet Rossant is a member of the Board of Directors of Notch Therapeutics; a member of the editorial board of Stem Cell Reports; and a member of the editorial board of Cell Stem Cell.

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References

    1. Anderson R.H., Wilkinson J.L., Arnold R., Lubkiewicz K. Morphogenesis of bulboventricular malformations. I. Consideration of embryogenesis in the normal heart. Br. Heart J. 1974;36:242–255. - PMC - PubMed
    1. Chen D., Liu W., Lukianchikov A., Hancock G., Zimmerman J., Lowe M., Lim R., Galic Z., Irie N., MA S. Germline competency of human embryonic stem cells depends on eomesodermin. BOR. 2017;97:850–861. - PMC - PubMed
    1. Deglincerti A., Croft G.F., Pietila L.N., Zernicka-Goetz M., Siggia E.D., Brivanlou A.H. Self-organization of the in vitro attached human embryo. Nature. 2016;533:251–254. - PubMed
    1. Eppig J.J., O'Brien M.J. Development in vitro of mouse oocytes from primordial follicles. Biol. Reprod. 1996;54:197–207. - PubMed
    1. Gerri C., Menchero S., Mahadevaiah S.K., Turner J.M.A., Niakan K.K. Human embryogenesis: a comparative perspective. Annu. Rev. Cell Dev. Biol. 2020;36:411–440. - PubMed