title: Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations.
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.
authors.affiliation: Centre for Biomedical Ethics, National University of Singapore, Level 2 Block MD11, Clinical Research Centre, 10 Medical Drive, 117576, Singapore, Singapore. tlysaght@nus.edu.sg.
authors.forename: Tamra
authors.identifier: http://orcid.org/0000-0002-7125-4206
authors.initials: T
authors.lastname: Lysaght
authors.affiliation: Centre for Values, Ethics and the Law in Medicine, University of Sydney, Medical Foundations Building K25, Sydney, NSW, 2006, Australia.
authors.forename: Ian H
authors.initials: IH
authors.lastname: Kerridge
authors.affiliation: RIKEN Centre for Developmental Biology, 2-2-3 Minatojima-minamimachi Chuou-ku, Kobe, 650-004, Japan.
authors.forename: Douglas
authors.initials: D
authors.lastname: Sipp
authors.affiliation: School of Law, Edinburgh University, Old College, South Bridge, Edinburgh, EH8 9YL, Scotland.
authors.forename: Gerard
authors.initials: G
authors.lastname: Porter
authors.affiliation: Department of Bioethics, Dalhousie University, 5849 University Avenue, Room C-315, CRC Bldg, PO Box 15000, Halifax, NS, B3H 4R2, Canada.
authors.forename: Benjamin J
authors.initials: BJ
authors.lastname: Capps
mesh_terms: D053687:Adult Stem Cells / Q000637:transplantation*; D001315:Australia; D003431:Cross-Cultural Comparison; D004992:Ethics, Medical; D033161:Government Regulation; D006801:Humans; D007391:International Cooperation; D007564:Japan; D009014:Morals; D012846:Singapore; D033581:Stem Cell Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence; D014182:Transplantation, Autologous / Q000941:ethics / Q000331:legislation & jurisprudence; D006113:United Kingdom; D014481:United States; D035862:Vulnerable Populations
keywords: Bioethics; Medical law; Science regulation; Stem cell therapies