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

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Abstract

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.

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Notes

  1. Adult refers here to the fact that the cells are non-embryonic and have limited potency.

  2. A third route, oriented towards the development of a therapeutic product, but on a much more modest scale, involves the search for what is known as an ‘orphan indication’, a therapy developed specifically to treat a rare medical condition. By definition, the market for such products is limited, but firms that win a product licence will enjoy an effective monopoly.

  3. Fieldwork related to an (Economic and Social Research Council) ESRC-funded project, ‘Quality Assured Science: The Role of Standards in Stem Cell Research’ (RES-340-25-0004) and an (European Commission) EC-funded project, REMEDiE (see www.york.ac.uk/satsu/remedie).

  4. See Lock and Nguyen (2010) for a related discussion of ‘techno/biologicals’.

  5. In the early 1990s, foetal tissue transplantation was used for experimental treatment for Parkinson's disease (Freed et al, 1990). In this case, every treated patient received transplants from about six different foetuses, which not only raises moral issues, but also issues of demand/supply. What is then needed is an operative, demand-driven tissue economy (Kent, 2008; see Waldby and Mitchell, 2006).

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Acknowledgements

Some of the data for this article were derived from the FP7-funded REMEDiE Project; we would also like to thank Ingrid Metzler for comments on an earlier draft of this article. Catherine Waldby would like to acknowledge the support of an International Program Development Fund grant, University of Sydney for this research.

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Authors and Affiliations

  1. Department of Sociology, University of York, Heslington, York, YO10 5DD, UK

    Andrew Webster

  2. Life-Science-Governance Research Platform, University of Vienna, Universitätsstr. 7, 2nd Floor. Room D 216, Vienna, Austria

    Christian Haddad

  3. Department of Sociology and Social Policy, University of Sydney, Room 167, RC Mills Building, Sydney, 2006, NSW, Australia

    Catherine Waldby

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  1. Andrew Webster
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  2. Christian Haddad
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  3. Catherine Waldby
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Correspondence to Andrew Webster.

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Webster, A., Haddad, C. & Waldby, C. Experimental heterogeneity and standardisation: Stem cell products and the clinical trial process. BioSocieties 6, 401–419 (2011). https://doi.org/10.1057/biosoc.2011.17

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