Experimental heterogeneity and standardisation: Stem cell products and the clinical trial process

This article examines developments in the field of regenerative medicine with respect to two quite distinct models of therapeutic development, a medical innovation model and a cells-as-drugs model. It seeks to contribute to our understanding of regenerative medicine clinical trials, by exploring the ways in which the contingencies that shape all trial processes are given particular expression in stem cell trials. Drawing on both primary and secondary data, the article examines the two main trajectories taken by biomedical innovation, one based on patient-specific therapies, the other more akin to the innovation path seen in the pharmaceutical sector. Each path raises distinct scientific, regulatory and commercial challenges and uncertainties for those involved. We analyse the implications of these two paths for our understandings of regenerative medicine and the innovation process more generally.