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. 2018 Nov 13;11(5):1021-1025.
doi: 10.1016/j.stemcr.2018.10.020.

Tackling Ethical Challenges of Premature Delivery of Stem Cell-Based Therapies: ISSCR 2018 Annual Meeting Focus Session Report

Affiliations

Tackling Ethical Challenges of Premature Delivery of Stem Cell-Based Therapies: ISSCR 2018 Annual Meeting Focus Session Report

Jeremy Sugarman et al. Stem Cell Reports. .

Abstract

Clinical uses of unproven stem cell-based interventions abound, yet many patients may be harmed by receiving them, raising complex ethical, economic, and societal concerns. Regulators, scientists, clinicians, professional societies, and patient advocacy groups need to collaboratively articulate expectations related to the proper development and delivery of stem cell-based therapies.

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Conflict of interest statement

J.S. is a member of Merck KGaA’s Bioethics Advisory Panel and Stem Cell Research Oversight Committee; and he is a member of IQVIA’s (formerly Quintiles) Ethics Advisory Panel. R.B. sits on the advisory boards of FCDI, Novo Nordisk, LCT, and Oxford Biomedica. I.K. is a Bone Marrow Transplant Physician, vice-President of the Bone Marrow Transplant Society of Australia and New Zealand and a board member of the NSW Stem Cell Network. He actively recruits patients to industry-funded clinical trials but does not receive any honoraria, salary, research, educational, or travel support from industry. G.P. is a member of the board of directors of Holostem Terapie Avanzate, Modena, Italy and consultant of J-TEC, Gamagori, Japan. D.S., T.L., and C.T. have no conflicts to disclose.

References

    1. Barker R.A., Carpenter M.K., Forbes S., Goldman S.A., Jamieson C., Murry C.E., Takahashi J., Weir G. The challenges of first-in-human stem cell clinical trials: what does this mean for ethics and Institutional Review Boards? Stem Cell Reports. 2018;10:1429–1431. - PMC - PubMed
    1. Berkowitz A.L., Miller M.B., Mir S.A., Cagney D., Chavakula V., Guleria I., Aizer A., Ligon K.L., Chi J.H. Glioproliferative Lesion of the spinal cord as a complication of “stem-cell tourism”. N. Engl. J. Med. 2016;375:196–198. - PubMed
    1. Bianco P., Cao X., Frenette P.S., Mao J.J., Robey P.G., Simmons P.J., Wang C.Y. The meaning, the sense and the significance: translating the science of mesenchymal stem cells into medicine. Nat. Med. 2013;19:35–42. - PMC - PubMed
    1. Horowitz M. The role of registries in facilitating clinical research in BMT: examples from the Center for International Blood and Marrow Transplant Research. Bone Marrow Transplant. 2008;42(Suppl 1):S1–S2. - PubMed
    1. Kimmelman J., London A.J. The structure of clinical translation: efficiency, information, and ethics. Hastings Cent. Rep. 2015;45:27–39. - PubMed

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