Unruly Objects: Novel Innovation Paths, and Their Regulatory Challenge

Abstract

During the last 15 years, stem cells have become sites of individual and collective human aspirations, where different scientific, medical, and economic visions and desires have been inscribed and contested, leading to multifold disputes and political controversies. Stem cells made headlines in the global mass media, and became a topic of electoral campaigns and heated parliamentary debates. They have brought stakeholders from different fields together into novel regulatory committees and expert bodies.1 In recent years, the focus of political and policy attention, professional and public concerns, as well as modes of expert deliberation shifted from basic biological research to efforts to apply these insights in clinical therapies, as stem cells moved into clinical research trials and experimental use (Webster et al., 2011). This push towards the clinic has not been a continuous or homogeneous process, but is characterised by striking frictions and heterogeneities in temporal and spatial terms, as well as with regard to practices. In 2010, a US biotech company, after years of preclinical development and intense relations with the competent regulatory authorities, announced the first embryonic stem cell therapy for initial human clinical trials (Roberts, 2010), while in China, a network of stem cell labs, tissue banks, researchers, and affiliated clinics reported to have already treated several hundreds of patients with their own adult stem cells (Cyranoski, 2009).