Stem cells clinical trials for cardiac repair: regulation as practical accomplishment

Abstract

Macro-analyses on the regulation of new biomedical objects tend to focus on discursive structures and legislative categories in science policy debates at national and cross-national levels, but overlook how actors engage in regulatory practices on an everyday basis. Based on data from ethnographic fieldwork in British and German clinics, and 32 interviews with medical staff, this article provides an insight into the regulation of adult stem cell research and its clinical implementation. The argument illustrates the enactment of regulation at different stages and highlights the accompanying interpretative strategies employed by the medical personnel involved in the management of clinical trials using patients' own (autologous) stem cells to regenerate damaged cardiac tissue. We argue that the implementation of regulation is a practical accomplishment in both national contexts. The complexities present in this process are instanced by the gradual crystallisation of practices within the organisation of clinical trials. This crystallisation is dependent on exchanges between members of medical teams and external agencies, and is set within a strategic ordering of regulatory measures that are mobilised to legitimise clinical research and reinforce professional interests.

Enculturating Cells: The Anthropology, Substance, and Science of Stem Cells

“…The banning of stem cell research in Austria is situated in its unique national context and is shown to be a result of a complex web of discourses and practices that serve to compensate for the loss of "political importance" and "moral integrity," which Austria experienced in the twentieth century. On the other hand, arguing that the implementation of regulation is a practical accomplishment in both Germany and the United Kingdom, Wilson-Kovacs et al (2010) show that the enactment of regulation at different stages together with interpretative strategies employed by medical personnel involved in managing clinical trials using autologous (patient's own) stem cells is perceived mainly as a necessary "passage point" (p. 99). The German national context, however, is unique in being able to invert "scientific" and "ethical" criteria to mean "doing stem cell research ethically" means "doing stem cell research scientifically" (Sperling 2008, p. 363).…”

The clinician‐scientist: professional dynamics in clinical stem cell research

“…Moreover, while the role played by regulation in the organisation of clinical trials using autologous stem cells for heart repair has been addressed (Wilson‐Kovacs et al 2010) the figure of the clinician‐scientist in this process remains largely overlooked. In SCR, double‐blinded RCTs represent the scientific medical standard for establishing new therapies in the clinic (Yeo and Mathur 2009).…”

Framing pluripotency: iPS cells and the shaping of stem cell science

“…The two countries have contrasting regulations governing stem cell research. 1 Drawing on accounts from researchers working in two different regulatory regimes has enabled our research group to examine the relationship between national regulatory contexts and the construction of research practices and objects (Wilson-Kovacs et al 2010, Weber et al 2011) and different national regulatory contexts of stem cell research have been studied in detail (e.g. Gottweis 2002, Hauskeller 2004, Schmidt et al 2004, Bender et al 2005, Campbell 2005, Jasanoff 2005, Prainsack et al 2008.…”