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

Abstract

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 generally.

Keywords:

• regulation
• regulatory space
• stem cell research
• cardiology
• clinical trials

Acknowledgements

This article results from the joint research of the team involved in the Stem Cell Research in Context: A Comparative Study on the Dynamic Relationship between Science, Medicine, and Society project (RES-349-25-0002), an Economic and Social Research Council (ESRC) funded study in Egenis, the ESRC Centre for Genomics in Society at the University of Exeter. The research was initiated and led by Dr Christine Hauskeller, with Drs Susanne Weber and Dana Wilson-Kovacs conducting most of the interviews and fieldwork. The authors wish to thank Susanne Weber for her contribution. The support of the ESRC is gratefully acknowledged.

Notes

1. The EU Tissue and Cells Directive 2004/23/EC and the Advanced Therapy Medicinal Products Regulation ATMP EC 1394/2007.

2. The EU Tissue and Cells Directive 2004/23/EC.

3. See http://www.esrc.ac.uk/my-esrc/grants/RES-349-25-0002/read [accessed 28 July 2012].

4. The Medicinal Products Directive 2001/83/EC OJ L311/67, Amendment Directive 2003/63/EC OJ L159/46, Regulations (EC) no. 726/2004 OJ L136/1, (EC) no. 1394/2007 OJL324/121 (Advanced Therapies Regulation). GCP and GMP provisions within medicinal products regulation: Good Clinical Practice Directives 2001/20/EC OJ L121/34, 2005/28/EC OJ L91/13, and GMP Directive 2003/94/EC OJ 262/22.

5. Clinical Trials Directive 2001/20/EC.

6. Advanced Therapy Medicinal Products Regulation ATMP EC 1394/2007.

7. EU Framework Programme 7 Health. The effect of intracoronary reinfusion of bone marrow-derived mononuclear cells (BM-MNC) on all-cause mortality in acute myocardial infarction. Available at: http://www.euram.ltd.uk/BAMI/ [accessed 21 July 2012].

8. See http://www.acmedsci.ac.uk/index.php?pid=47&prid=88 [accessed 21 June 2011].