TY - JOUR
T1 - Ethical and Regulatory Challenges with Autologous Adult Stem Cells
T2 - A Comparative Review of International Regulations
AU - Lysaght, Tamra
AU - Kerridge, Ian H.
AU - Sipp, Douglas
AU - Porter, Gerard
AU - Capps, Benjamin J.
N1 - Publisher Copyright:
© 2017, Journal of Bioethical Inquiry Pty Ltd.
PY - 2017/6/1
Y1 - 2017/6/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85014039935&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85014039935&partnerID=8YFLogxK
U2 - 10.1007/s11673-017-9776-y
DO - 10.1007/s11673-017-9776-y
M3 - Article
C2 - 28247202
AN - SCOPUS:85014039935
SN - 1176-7529
VL - 14
SP - 261
EP - 273
JO - Journal of Bioethical Inquiry
JF - Journal of Bioethical Inquiry
IS - 2
ER -