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Xenotransplantation pp 307–329Cite as

Some Ethical, Social, and Legal Considerations of Xenotransplantation

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Part of the book series: Methods in Molecular Biology ((MIMB,volume 885))

Abstract

Xenotransplantation has changed its focus from solid organs to cells and tissues, and it is now mainly conceived of and regulated as a pharmaceutical product. Animal cell therapies are showing promising results and may involve fewer risks than organs. However, countries should be cautious about allowing xenotransplantation clinical trials to develop. Regulatory frameworks should contain specific conditions about the safety of the source animals, of the xenotransplantation product, and of the manufacturing process. In turn, these frameworks should ensure that preclinical studies indicate safety and efficacy of the procedure and that risk-management protocols are in place to identify, contain, and combat any outbreak of infection in a timely manner. The fragile balance between individual and collective rights and the tensions of globalization make necessary a coordinated international action to harmonize global practices in this field. Xenotransplantation clinical trials should be carried out in a context in which specific safety and ethical issues are addressed, and in an environment in which specific practices that facilitate public engagement as a form of shared responsibility for regulatory decision making are promoted as well.

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Acknowledgment

This work has been part-financed by the European Commission’s Sixth Framework Programme, under the priority thematic area “Life Sciences, Genomics and Biotechnology for Health”, contract no. LSHB-CT-2006-037377, Xenome.

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Authors and Affiliations

  1. University of Deusto, Bilbao, Spain

    María Jorqui Azofra & Carlos María Romeo Casabona

  2. University of the Basque Country, Bilbao, Spain

    María Jorqui Azofra & Carlos María Romeo Casabona

Authors
  1. María Jorqui Azofra
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  2. Carlos María Romeo Casabona
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Corresponding author

Correspondence to María Jorqui Azofra .

Editor information

Editors and Affiliations

  1. Bellvitge (IDIBELL), Hospital Duran i Reynals, Institut d'Investigació Biomèdica de, Gran Via de L’Hospitalet 199, L’Hospitalet de Llobregat, 08908, Barcelona, Spain

    Cristina Costa

  2. Servicio de Medicina Intensiva, Hospital Universitario de Bellvitge, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain

    Rafael Máñez

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Azofra, M.J., Casabona, C.M.R. (2012). Some Ethical, Social, and Legal Considerations of Xenotransplantation. In: Costa, C., Máñez, R. (eds) Xenotransplantation. Methods in Molecular Biology, vol 885. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-61779-845-0_19

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  • DOI: https://doi.org/10.1007/978-1-61779-845-0_19

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  • Publisher Name: Humana Press, Totowa, NJ

  • Print ISBN: 978-1-61779-844-3

  • Online ISBN: 978-1-61779-845-0

  • eBook Packages: Springer Protocols

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