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. (shrink)

The commercial provision of putative stem cell-based medical interventions in the absence of conclusive evidence of safety and efficacy has formed the basis of an unregulated industry for more than a decade. Many clinics offering such supposed stem cell treatments include statements about the ‘ethical’ nature of somatic stem cells, in specific contrast to human embryonic stem cells, which have been the subject of intensive political, legal, and religious controversy since their first derivation in 1998. Christian groups—both Roman Catholic and (...) evangelical Protestant—in many countries have explicitly promoted the medical potential and current-day successes in the clinical application of somatic stem cells, lending indirect support to the activities of businesses marketing stem cells ahead of evidence. In this article, I make a preliminary examination of how the structures and belief systems of certain churches in South Korea and the United States, both of which are home to significant stem cell marketing industries, has complemented other factors, including national biomedical funding initiatives, international economic rivalries, permissive legal structures, which have lent impetus to a problematic and often exploitative sector of biomedical commerce. (shrink)

The global industry engaged in direct-to-consumer marketing of unproven stem cell-based interventions has undergone sweeping changes over the past decade. Two of the most striking developments in recent years have been the emergence of stem cell marketing businesses in highly developed nations, such as the United States, Japan, and Australia, and the industry's convergence on a much narrower range of supposedly therapeutic cell types than in the past. The greatest number of businesses advertising unproven uses of stem cells in English (...) are now in the US, and the majority of those promote unproven therapeutic uses of autologous cells (see Supplementary Table S1 in Turner and... (shrink)