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Journal of Bioethical Inquiry

, Volume 14, Issue 2, pp 261–273 | Cite as

Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations

  • Tamra Lysaght
  • Ian H. Kerridge
  • Douglas Sipp
  • Gerard Porter
  • Benjamin J. Capps
Original Research

Abstract

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.

Keywords

Bioethics Stem cell therapies Medical law Science regulation 

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Copyright information

© Journal of Bioethical Inquiry Pty Ltd. 2017

Authors and Affiliations

  1. 1.Centre for Biomedical EthicsNational University of SingaporeSingaporeSingapore
  2. 2.Centre for Values, Ethics and the Law in MedicineUniversity of SydneySydneyAustralia
  3. 3.RIKEN Centre for Developmental BiologyKobeJapan
  4. 4.School of LawEdinburgh UniversityEdinburghScotland
  5. 5.Department of BioethicsDalhousie UniversityHalifaxCanada

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