Cardiac stem cell research: regulation and practice in the UK and Germany

Debates on the regulation of stem cell research (SCR) tend to center on the governance of ethically contested stem cells (i.e. human embryonic), focus on the macro-dynamics of science development and the role of legislative bodies, and rely on documentary resources. They also largely ignore regulatory dynamics in adult SCR, where clinical trials have brought SCR closer to application. This article examines the contextual elaboration of novel medical treatment regulation in relation to stem cell therapies for heart repair using adult stem cells, in two European countries, the UK and Germany. It presents some of the challenges regulation poses in practice for both regulators and clinical teams, and discusses how the tension between the creation and maintenance of standards and the development of new treatments is understood by the regulators themselves. The conclusion evaluates the significance of regulatory practices in the production of new stem cell therapies in particular and innovative treatments more ...