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Tissues and Cells: MSM Donor Selection Review

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Tissues and Cells: MSM Donor Selection Review Tissues and Cells: MSM* Donor Selection Review July 2013 *MSM – men who have had sex with men Page 1 of 149 Table of Contents 1. Executive summary .................................................................................. 7 1.1. Background .................................................................................... 7 1.2. Methodology .................................................................................. 7 1.3. Recommendations on donor deferral ............................................. 8 1.3.1. Group 1: Haematopoietic stem cells, whether from family and friends, or unrelated adult donors, or from cord blood. ............... 8 1.3.2. Group 2: Pancreatic islets and hepatocytes ............................... 9 1.3.3. Group 3: Banked tissues (corneas, heart valves, bone, skin, amnion and tendon) ..................................................................................... 9 1.3.4. Group 4: Sperm, eggs and embryos ......................................... 10 1.4. Other observations ....................................................................... 10 1.4.1. Observations on collection of donor information .......................... 10 1.4.2. Observations on donation testing ................................................. 10 1.4.3. Observations on manufacturing ................................................... 10 1.4.4. Observations on bio vigilance ...................................................... 11 2. Background ............................................................................................. 12 3. Scope ..................................................................................................... 13 3.1. In scope ....................................................................................... 13 3.2. Out of scope ................................................................................. 13 4. Factors considered in risk assessment of each tissue/cell product. ........ 14 4.1. Is the product life-saving or life-enhancing? ................................. 14 4.2. Adequacy of general supply, and meeting of donor:patient matching requirements. .............................................................................. 14 4.3. Source of donors and depth of donor assessment. ...................... 15 4.4. Are there infectious agents of concern for individual tissues? ...... 15 4.5. Maximum number of recipients who could receive cells/tissues from a single donor. ............................................................................. 15 4.6. Current practice regarding repeat testing of the donor. ................ 15 4.7. Whether there is the opportunity to discuss with the patient’s clinician possible risks relating to an individual donor. ............................... 16 4.8. Summary table ............................................................................. 16 5. Infectious agents relevant to tissues and cells, and their epidemiology in the UK ..................................................................................................... 18 5.1. Considerations ............................................................................. 18 5.2. Key points re donor screening ..................................................... 18 5.3. Epidemiology ............................................................................... 19 5.4. Infections of interest for which testing is currently mandatory. ..... 21 5.4.1. Hepatitis B virus (HBV) ................................................................ 21 5.4.2. Hepatitis C virus (HCV) ................................................................ 21 5.4.3. Human immunodeficiency virus (HIV) .......................................... 22 5.4.4. Human T-cell lymphotropic virus (HTLV) .................................... 22 5.4.5. Treponema pallidum .................................................................... 23 5.5. Infections of potential significance for sperm, eggs and embryo donation ....................................................................................... 23 5.5.1. Herpes simplex virus .................................................................... 23 5.5.2. Chlamydia trachomatis ................................................................. 23 5.5.3. Neisseria gonorrhoea ................................................................... 24 Page 2 of 149 5.6. Other infections of interest ........................................................... 24 5.6.1. Hepatitis A (HAV) ......................................................................... 24 5.6.2. Cytomegalovirus (CMV) ............................................................... 24 5.6.3. Epstein Barr Virus (EBV) .............................................................. 25 5.6.4. HHV-8 / Kaposi sarcoma herpes virus (KSHV) ............................ 25 5.6.5. Conclusions on HHV-8 ................................................................. 30 5.7. Epidemiology of infections in current UK donor population .......... 31 5.7.1. Tissue and cord blood donors from England 2011 ....................... 31 5.7.2. Cumulative tissue donor data 2001-2011 ..................................... 31 5.7.3. Tissue and cord blood donors from Scotland (2005-2011) and Northern Ireland (2007-2011) ....................................................... 31 5.7.4. Anthony Nolan: stem cells, data supplied by Anthony Nolan ....... 32 5.7.5. British Bone Marrow Registry (BBMR): stem cells ....................... 32 5.7.6. Comparison of blood and tissue donors ....................................... 32 5.7.7. Risk exposures, age and ethnicity of infected tissue and cell donors tested by NHS Blood and Transplant (NHSBT) ................ 35 5.7.8. Age and gender of donors ............................................................ 37 5.7.9. Post-transplant infections ............................................................. 37 5.8. Estimates of residual risk of not detecting hepatitis B or C window period infection in surgical bone donors. ...................................... 38 5.9. Emerging infections ...................................................................... 40 6. Tissue-specific risk assessments ............................................................ 41 6.1. Process ........................................................................................ 41 6.2. Haemopoietic stem cells (HSC) and lymphocytes ....................... 42 6.2.1. Background .................................................................................. 42 6.2.2. Context ......................................................................................... 42 6.2.3. Donor ........................................................................................... 48 6.2.4. Testing ......................................................................................... 51 6.2.5. Processing ................................................................................... 56 6.2.6. Recipient(s) .................................................................................. 56 6.3. Pancreatic islets and hepatocytes ................................................ 57 6.3.1. Background .................................................................................. 57 6.3.2. Context ......................................................................................... 57 6.3.3. Donor ........................................................................................... 59 6.3.4. Testing ......................................................................................... 60 6.3.5. Processing ................................................................................... 61 6.3.6. Recipient(s) .................................................................................. 61 6.4. Banked tissues ............................................................................. 62 6.4.1. Background .................................................................................. 62 6.4.2. Context ......................................................................................... 62 6.4.3. Testing ......................................................................................... 70 6.4.4. Processing ................................................................................... 71 6.4.5. Recipients .................................................................................... 74 6.5. Gametes and embryos ................................................................. 75 6.5.1. Background .................................................................................. 75 6.5.2. Context ......................................................................................... 77 6.5.3. Donor ........................................................................................... 79 6.5.4. Testing ......................................................................................... 81 6.5.5. Processing ................................................................................... 82 6.5.6. Recipients .................................................................................... 82 Page 3 of 149 7. Recommendations and observations ...................................................... 84 7.1. Recommendations on donor deferral ........................................... 84 7.1.1. Group 1: Haematopoietic stem cells, whether from family and friends, or unrelated adult donors, or from cord blood.................. 84 7.1.2. Group 2: Pancreatic
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