ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update.

The International Society for Stem Cell Research has updated its Guidelines for Stem Cell Research and Clinical Translation in order to address advances in stem cell science and other relevant fields, together with the associated ethical, social, and policy issues that have arisen since the last update in 2016. While growing to encompass the evolving science, clinical applications of stem cells, and the increasingly complex implications of stem cell research for society, the basic principles underlying the Guidelines remain unchanged, and they will continue to serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. A summary of the key updates and issues is presented here.

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Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

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Declaration of interests R.L.-B. has no financial conflicts to declare. R.L.-B. serves on the following advisory boards: Scientific and Clinical Advances Advisory Committee of the Human Fertility and Embryo Authority; Sense About Science, Member of Board of Trustees; Public Library of Science (PLOS), Board Member, Chair of Audit Committee, Chair of Remunerations Committee, and member of Scientific Advisory Board; Royal Society, Chair of “Genetic Technologies Programme,” Progress Educational Trust, Chair of the Board of Trustees; member of the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing; Chair of ISSCR Task Force to Update the Guidelines; and member of External Advisory Board, “Cambridge Reproduction Strategic Research Initiative,” University of Cambridge, UK. R.B. receives funding from UK NIHR, MRC, Wellcome, Cure Parkinson’s Trust, and EU. R.B. received funding from Parkinson’s UK, CHDI, Rosetrees Trust, and Evelyn Trust. R.B. receives royalties from Wiley and Springer and also has an ongoing consultancy role for the following companies: Novo Nordisk, UCB, Aspen Neuroscience, and BlueRock Therapeutics. A.H.B. is a co-founder of OvaNova, Inc., as well as a co-founder of Rumi Scientific, Inc. R.A.C. is Professor Emerita, University of Wisconsin; David Hamburg Fellow, Nuclear Threat Initiative; and Lead Co-Chair, BioMADE. R.A.C is a member of the WHO Expert Advisory Group on Genome Editing; member of the Planning Committee, Third International Summit on Genome Editing; and Co-Chair of the US National Academy of Medicine committee on emerging science, technology, and innovation. A.C. is a board member of the ISSCR and scientific advisory board member of the Tepper Foundation. G.Q.D. holds patents relevant to stem cells and is a founder of and member of the scientific advisory board of 28/7 Therapeutics, Inc. S.G. is also a part-time employee and stock-holder of Sana Biotechnology, a cell therapy company; he holds relevant patents and his lab receives sponsored research support from Sana. A.G. is a current or recent board member of the following: the National Academies International Commission on Heritable Human Genome Editing; the UK HFEA’s Scientific & Clinical Advances Advisory Committee; and the UK Nuffield Council on Bioethics until 2020. A.G.’s core funding is from the Mammalian Genetics Unit at MRC Harwell (MC_U142684167). J.K. holds a patent on the cerebral organoid method and is co-founder and scientific advisory board member of a:head bio. D.J.H.M. 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. L.N. is an inventor on patents on lentiviral vector technology and targeted genome editing filed by Telethon Foundation and/or San Raffaele Scientific Institute. L.N. is a founder and/or owns equity and is a scientific advisory board member of Genenta Science, Magenta Therapeutics, Genespire, and Tessera. R.P. is an advisor and has stock options in BIT BIO. J.R. is a member, Board of Directors, Notch Therapeutics; member, Editorial Board, Stem Cell Reports; and member, Editorial Board, Cell Stem Cell. N.R. is an inventor on two patents describing the blastoid technology (EP2986711 and EP21151455.9). N.R. 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. M.S. is affiliated with the following: Institute for the Advanced Study of Human Biology (WPI-ASHBi), Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan; Department of Anatomy and Cell Biology, Graduate School of Medicine, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan; and Center for iPS Cell Research and Application (CiRA), Kyoto University, 53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan. M.S. is an inventor on patent applications relating to the induction of germ cells from PSCs filed by Kyoto University. J.S. is a member of Merck KGaA’s Bioethics Advisory Panel and Stem Cell Research Oversight Committee; a member of IQVIA’s Ethics Advisory Panel; a member of Aspen Neurosciences Scientific Advisory Board; a member of a Merck Data Monitoring Committee; a consultant to Biogen; and a consultant to Portola Pharmaceuticals, Inc. L.T. has no financial interests to declare. L.T. is member of ISSCR’s Ethics Committee and Membership Committee and was a member of one of the working groups involved in revising and updating ISSCR’s guidance document. The other authors declare no competing interests.