CONTENTS
Terms of Reference
Summary
Chapter 1: Introduction
Scope
Methodology
Structure of the report
Acknowledgements
Chapter 2: Definitions and examples
What is regenerative medicine?
Box 1: Definitions
Box 2: Cell definitions: types, potency and
therapy types
The value and importance of regenerative
medicine
Table 1: Number of people in the UK affected
by specific
Table 2: NHS programme budget expenditure
Government initiatives
Chapter 3: The Current landscape
Impact and excellence of the science
base
Historical strengths
Clinical trials
Figure 1: Clinical trial stages
Table 3: ATMP clinical trials in Europe in
the period 2004-10
Figure 2: Ongoing stem cell therapy clinical
trials in the UK
Box 3: Further examples of UK regenerative
medicine clinical trials
Industry
Figure 3: Regenerative medicine companies
broken down by European Union Member State
Figure 4: Type of regenerative medicine company
broken down by company size and region
Figure 5: Heat map of GB regenerative medicine
companies
Funding
Figure 6: TRL Stages
Figure 7: UK public sector spend on regenerative
medicine
Figure 8: Regenerative medicine spend by
TRL stage
Table 4: Regenerative Medicine Programme
grant funding 2009-11
Table 5: Biomedical Research Centre funded
regenerative medicine research
Table 6: Biomedical Research Unit funded
regenerative medicine research
Table 7: European Commission project funding
for regenerative medicine 2007-10
Chapter 4: Translation
Regulatory environment
Table 8: Regulators with jurisdiction over
regenerative medicine in the UK
Figure 9: Number of competent authorities
Clinical trials
Figure 10: Time Taken for the MHRA to assess
regenerative medicine clinical trial applications 2008-12
Figure 11: NIHR Biomedical Research Units
and Biomedical Research Centres
Scale-up and manufacturing
Table 9: Doses per year drives cell batch
size
Delivery
Chapter 5: Commercialisation
Business models, venture capital and
the funding gap
Intellectual Property
Evaluation and the pricing of treatments
Risks of regenerative medicine tourism
Hospital exemption
Harmonisation
Co-ordination and final conclusion
Chapter 6: Conclusions and recommendations
The value and importance of regenerative
medicine
Uncertainty
Regulatory environment
Clinical trials
Scale-up and manufacturing
Delivery
Business models, venture capital and the
funding gap
Intellectual Property
Evaluation and the pricing of treatments
Risks of regenerative medicine tourism
Hospital exemption
Harmonisation
Co-ordination and final conclusion
Appendix 1: List of Members and declarations
of interest
Appendix 2: List of witnesses
Appendix 3: Call for evidence
Appendix 4: Seminar held at King's College
London, Guy's Campus
Appendix 5: Visit to California Institute
for Regenerative Medicine (CIRM), United States
Appendix 6: Abbreviations and Acronyms
Appendix 7: Recent reports from the House
of Lords Science and Technology Committee
NOTE: Evidence is published online at http://www.parliament.uk/hlscience
and available for inspection at the Parliamentary
Archives (020 7219 5314)
References in footnotes to the Report are as follows:
Q refers to a question in oral evidence;
Witness names without a question reference refer
to written evidence.
| 
