The regulation of autologous stem cells in heart repair: comparing the UK and Germany<sup>1</sup>

Susanne Weber, Dana Wilson-Kovacs and Christine Hauskeller

in Human Tissue Research

Published in print March 2011 | ISBN: 9780199587551
Published online May 2011 | e-ISBN: 9780191725630 | DOI:
The regulation of autologous stem cells in heart repair: comparing the UK and Germany1

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This chapter presents a comparison of the legal and institutional integration of the EU Tissue and Cells Directive and medicinal product regulations on novel cell therapies in Germany and the UK. The argument is based on a detailed case study on one of the few stem cell therapies in patient application: clinical trials using autologous (patients' own) bone marrow stem cells for heart repair. While European regulations aim to harmonize the conditions for medical applications that use tissues and cells, the analysis exemplifies that the integration of these regulations is different in the two countries compared. The findings suggest that the differences in implementation reflect distinct approaches towards managing risks and resolving uncertainty in the development of novel cell therapies that may resist smooth European harmonization.

Keywords: stem cell therapies; EU tissue regulation; Advanced Therapies regulation; national comparison; European harmonization

Chapter.  5238 words. 

Subjects: Public Health and Epidemiology

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