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Safety, Regulatory, and Ethical Issues of Human Studies

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Biomaterials for Cardiac Regeneration

Abstract

To get approval for initiating a stem cell clinical trial is becoming increasingly difficult because of the stringency of regulatory guidelines. The first section of this chapter presents an outline of the major issues which should be kept in mind by investigators from the very early onset of the program so as to frame it in such a way that it may satisfactorily comply with the multiple constraints, thereby avoiding a waste of time, efforts, and money. While the regulators legitimately require proof of efficacy of the stem cell product and mechanistic insights before granting approval for a human study, their main concern still pertains to safety, particularly for first-in-man interventions. The next section of this chapter briefly summarizes the main cell-related complications that have happened or remain of concern, and which need to be addressed by a risk plan analysis. Finally, stem cells pose unique ethical problems, particularly when one is dealing with human pluripotent stem cells and some general considerations surrounding this ethical debate are presented in the last part of the chapter.

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Authors and Affiliations

  1. Paris Descartes University, Sorbonne Paris Cité, INSERM U 970, 20, rue Leblanc, 75015 Paris, France

    Yohan Farouz, Mathilde Cossé, Nisa Renault & Philippe Menasché

  2. Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Department of Cardiovascular Surgery, Paris Descartes University, Sorbonne Paris Cité, INSERM U 970, 20, rue Leblanc, 75015, Paris, France

    Philippe Menasché

Authors
  1. Yohan Farouz
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  2. Mathilde Cossé
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  3. Nisa Renault
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  4. Philippe Menasché
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Correspondence to Philippe Menasché .

Editor information

Editors and Affiliations

  1. Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada

    Erik J. Suuronen

  2. Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada

    Marc Ruel

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Farouz, Y., Cossé, M., Renault, N., Menasché, P. (2015). Safety, Regulatory, and Ethical Issues of Human Studies. In: Suuronen, E., Ruel, M. (eds) Biomaterials for Cardiac Regeneration. Springer, Cham. https://doi.org/10.1007/978-3-319-10972-5_11

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  • DOI: https://doi.org/10.1007/978-3-319-10972-5_11

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-10971-8

  • Online ISBN: 978-3-319-10972-5

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