22.1 Introduction - Haemopoietic progenitor cells

Cellular therapy is now covered by a variety of legislation.

The EU Directive on Tissues and Cells (2004/23/EC) and its associated Commission Directives (2006/17/EC and 2006/86/EC) have been transposed into UK law as the Human Tissue (Quality and Safety for Human Application) Regulations 2007 as amended.

The Human Tissue Act 2004, Human Tissue (Scotland) Act 2006 and Directions or Codes of Practice issued by the Human Tissue Authority (HTA) also apply.

In addition, there are a number of key international standards for haemopoietic stem cells, notably the FACT-JACIE and NetCord-FACT Standards and the WMDA standards. The lists of publications in 22.1.1 and 22.1.2 below have been grouped according to their origins.

The guideline references in this chapter apply to the donation, collection, testing, processing, cryopreservation, storage and distribution of haemopoietic progenitor cells (HPC) and mononuclear cells (MNC) within the UK. These guidelines are applicable to stem cell donor registries and to bone marrow, peripheral blood and cord blood collection and processing facilities, and importing facilities, hereafter mentioned as establishments.

22.1.1: UK Regulation/Guidelines

  1. Statutory Instrument 2007 No. 1523 The Human Tissue (Quality and Safety for Human Application) Regulations 2007 and subsequent amendments
  2. HTA Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment
  3. Human Tissue Act 2004 (except Scotland)
  4. Human Tissue (Scotland) Act 2006
  5. Human Tissue Authority Codes of Practice
    1. Guiding principles and the fundamental principle of consent (Code A)
    2. Donation of Allogeneic Bone Marrow and Peripheral Blood Stem Cells for Transplantation (Code G). 
  6. Human Tissue Authority Guidance document for establishments working with Umbilical cord blood
  7. Data Protection Act 2018
  8. BSHI guidelines for HLA matching and donor selection for haematopoietic progenitor cell transplantation
  9. JPAC Donor Selection Guidelines
    1. Bone Marrow and Peripheral Blood Stem Cell Donor Selection Guidelines
    2. Cord Blood Donor Selection Guidelines
  10. JPAC Geographical Disease Risk Index (GDRI)
  11. Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) Microbiological safety guidelines

22.1.2: European & International Directives/Guidelines

  1. EDQM Guide to the quality and safety of tissues and cells for human application
  2. EC Guidelines to Good Manufacturing Practice (Eudralex) Manufacture of Sterile Medicinal Products
  3. International Standards for Cellular Therapy Product Collection, Processing, and Administration from the Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-Europe and EBMT (JACIE)
  4. International Standards for Cellular Therapy Product Collection, Processing, and Administration Accreditation Manual
  5. NetCord-FACT International Standards for Cord Blood Collection, Banking and Release for Administration
  6. NetCord-FACT Cord Blood Accreditation Manual
  7. World Marrow Donor Association (WMDA) International Standards for Unrelated Haematopoetic Stem Cell Donor Registries
  8. European Federation for Immunogenetics (EFI) Standards for histocompatibility testing
  9. National Marrow Donor Program (USA) Standards
  10. WMDA Donor Medical Suitability Recommendations

Last updated on 4 September 2023