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Human Tissue ResearchA European perspective on the ethical and legal challenges$
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Christian Lenk, Nils Hoppe, Katharina Beier, and Claudia Wiesemann

Print publication date: 2011

Print ISBN-13: 9780199587551

Published to Oxford Scholarship Online: May 2011

DOI: 10.1093/acprof:oso/9780199587551.001.0001

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PRINTED FROM OXFORD SCHOLARSHIP ONLINE (oxford.universitypressscholarship.com). (c) Copyright Oxford University Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 21 January 2022

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

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

(p.159) Chapter 16 The regulation of autologous stem cells in heart repair: comparing the UK and Germany1
Human Tissue Research

Susanne Weber

Dana Wilson-Kovacs

Christine Hauskeller

Oxford University Press

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

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