Chapter 37. Regulation and Accreditation in Cellular Therapy

  1. Michael F. Murphy MD, FRCP, FRCPath Professor Consultant Haematologist2,3 and
  2. Derwood H. Pamphilon MD, MRCPCH, FRCP, FRCPath Consultant Haematologist Honorary Clinical Reader4,5
  1. Derwood H. Pamphilon MD, MRCPCH, FRCP, FRCPath Consultant Haematologist Honorary Clinical Reader4,5 and
  2. Zbigniew M. Szczepiorkowski MD, PhD Consultant Haematologist1

Published Online: 5 MAY 2009

DOI: 10.1002/9781444311761.ch37

Practical Transfusion Medicine, Third Edition

Practical Transfusion Medicine, Third Edition

How to Cite

Pamphilon, D. H. and Szczepiorkowski, Z. M. (2009) Regulation and Accreditation in Cellular Therapy, in Practical Transfusion Medicine, Third Edition (eds M. F. Murphy and D. H. Pamphilon), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444311761.ch37

Editor Information

  1. 2

    University of Oxford, Oxford, UK

  2. 3

    NHS Blood and Transplant and Department of Haematology, John Radcliffe Hospital, Oxford, UK

  3. 4

    NHS Blood and Transplant, Bristol, UK

  4. 5

    Department of Cellular and Molecular Medicine, University of Bristol, Bristol, UK

Author Information

  1. 1

    Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA

  2. 4

    NHS Blood and Transplant, Bristol, UK

  3. 5

    Department of Cellular and Molecular Medicine, University of Bristol, Bristol, UK

Publication History

  1. Published Online: 5 MAY 2009
  2. Published Print: 14 APR 2009

ISBN Information

Print ISBN: 9781405181969

Online ISBN: 9781444311761

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Keywords:

  • solid tumours and degenerative diseases;
  • cellular therapy;
  • haemopoietic stem cell transplant programmes;
  • chronic myeloid leukaemia (CML);
  • umbilical cord blood (CB);
  • human tissue act;
  • non-governmental accreditation;
  • FACT–JACIE accreditation;
  • therapeutic cells (TCs)

Summary

This chapter contains sections titled:

  • Introduction

  • Haemopoietic stem cell transplant activity

  • The structure of SCT programmes

  • European Union directives and legislation

  • The Human Tissue Act 2004

  • The US Food and Drug Administration

  • Non-governmental (voluntary) accreditation

  • Conclusions: how do HSCT programmes respond to the challenge?

  • Key points

  • Further reading