4006: Cellular Therapy Infusion
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1 4006: Cellular Therapy Infusion Registry Use Only Sequence Number: Date Received: Key Fields CIBMTR Center Number: Event date: / / CIBMTR Form 4006 revision 1 (page 1 of 9). Last Updated July, 2016.
2 If more than one type of cell therapy product is infused, each product type must be reported separately. Cellular Therapy Product Identification Questions: Specify donor: Autologous - Go to question 7 Autologous cord blood unit - Go to question 6 NMDP unrelated cord blood unit - Go to question 3 NMDP unrelated donor - Go to question 4 Related donor - Go to question 7 Related cord blood unit - Go to question 6 n-nmdp unrelated donor - Go to question 5 n-nmdp unrelated cord blood unit - Go to question 6 Other - Go to question 2 2. Specify: - Go to question NMDP Cord Blood Unit ID: - Go to question NMDP Donor ID: - Go to question Non-NMDP unrelated donor ID: (not applicable for related donor) - Go to question 7 6. Non-NMDP cord blood unit ID: (include related and autologous CBUs) - Go to question 7 7. Is there an ISBT DIN number associated with the product? If yes, cord blood go to question 8, all other products go to question 9 8. Is the CBU ID also the ISBT DIN number? 9. Specify the ISBT DIN number: - Autologous go to question 17, Related donor go to question 12, Non-nmdp unrelated donors go to question 10, Non-nmdp cord blood unit go to question Registry or UCB Bank ID: - If other, go to question Specify other Registry or UCB Bank: 12. Date of birth (donor / infant): Known ` 13. / / - Go to question Age (donor / infant): Known 15. Age (donor / infant): Months (use only if <1 year old) Years - Go to question 16 CIBMTR Form 4006 revision 1 (page 2 of 9). Last Updated July, 2016.
3 16. Sex (donor / infant): Male Female Specify any identifiers associated with this cell product: 17. Cell product ID 18. Cell product ID: 19. Batch number 21. Lot number 20. Batch number: 22. Lot number: 23. Where was the cellular therapy product manufactured? Pharmaceutical / biotech company - Go to question 25 Cell processing laboratory off site - Go to question 26 Cell processing laboratory at the same center as the product is being infused - Go to question 27 Other site - Go to question Specify other site: - Go to question Specify pharmaceutical / biotech company vartis Juno Therapeutics Celgene Kite Pharma Blue Bird Biotec Other pharmaceutical company Specify the institution / company where the cellular product was manufactured: 26. Name: City: State: Country: Cell Product Source Questions: Date of cell product collection Known 28. Date of cell product collection: / / 29. What is the tissue source of the cellular product? Bone marrow Cord blood unit CIBMTR Form 4006 revision 1 (page 3 of 9). Last Updated July, 2016.
4 Peripheral blood Adipose tissue Amniotic fluid Cardiac tissue Hepatic tissue Neuronal tissue Ophthalmic tissue Pancreatic tissue Placenta Tumor Umbilical cord Other tissue source 30. Specify other tissue source: 31. What is the cell type? Lymphocytes (unselected) CD4+ lymphocytes CD8+ lymphocytes Natural killer cells (NK cells) Dendritic cells / tumor cell hybridomas (tumor vaccines) Mesenchymal stromal stem cells (MSCs) Unspecified mononuclear cells Endothelial progenitor cells Human umbilical cord perivascular (HUCPV) cells Cardiac progenitor cells Islet cells Oligodendrocytes Other cell type 32. Specify other cell type: Copy and complete questions for each cell type infused as part of this product Cell Product Manipulation Questions: Were the cells in the infused product selected / modified / engineered prior to infusion? 34. Specify the portion manipulated: Entire product Portion of product 35. Was the unmanipulated portion of the product also infused? 36. Was the same manipulation method used on the entire product / all portions of the product? CIBMTR Form 4006 revision 1 (page 4 of 9). Last Updated July, 2016.
5 Specify all methods used to manipulate the product: 37. Cultured (ex-vivo expansion) 38. Induced cell differentiation 39. Cell selection (positive or negative) 40. Cell selection based on affinity to a specific antigen 41. Genetic manipulation (gene transfer / transduction) Specify the type of genetic manipulation 42. Transfection 43. Viral transfection 44. Lentivirus 45. Retrovirus 46. Non-viral transfection: 47. Transposon 48. Electroporation 49. Other non-viral transfection 50. Specify other non-viral transfection: 51. Gene editing 52. Specify gene CCR5 Factor IX Factor VIII Other gene 53. Specify other gene: 54. Other genetic manipulation 55. Specify other genetic manipulation: 56. Were cells engineered to express a non-native antigen receptor? 57. Specify the construct utilized: T-cell receptor Go to question 60 Chimeric Antigen Receptor (CAR) 58. Specify details of the CAR construct: CD3ζ Go to question 60 CD27 Go to question 60 CD28 Go to question 60 ICOS Go to question 60 OX40 Go to question BB Go to question 60 EGFR Go to question 60 Other construct 59. Specify other construct: Copy and complete questions if more than one construct was utilized CIBMTR Form 4006 revision 1 (page 5 of 9). Last Updated July, 2016.
6 60. Was the product manipulated to recognize a specific target/antigen? 61. Specify target Viral Go to question 62 Tumor / cancer antigen Go to question 70 Other target Go to question 73 Targets specific to viral infections 62. Adenovirus 63. BK virus 64. Cytomegalovirus (CMV) 65. Epstein-Barr virus (EBV) 66. Human herpes virus Human Immunodeficiency Virus (HIV) 68. Other virus 69. Specify other virus: Targets specific to tumors 70. Tumor / cancer antigen 71. Specify the target antigen: CD19 CD20 CD22 CD30 CD33 CD138 BCMA Lewis-Y Other target antigen 72. Specify tumor / cancer antigen: 73. Other target: 74. Specify other target: 75. Other cell manipulation 76. Specify other cell manipulation: CIBMTR Form 4006 revision 1 (page 6 of 9). Last Updated July, 2016.
7 Cell Product Analysis Questions: Was transfection efficiency done? (genetically engineered cells) 78. Date: / / 79. Transfection efficiency: % 80. Was transfection efficiency target achieved? 81. Viability of cells Done t done 82. Date: / / 83. Viability of cells: % 84. Method of testing cell viability: 7-AAD Propidium iodide Trypan blue Other method 85. Specify other method: Product Infusion Questions: Date of this product infusion: / / 87. Was the entire volume of product infused? 90. Specify the route of product infusion: Intravenous Intramedullary Intraperitoneal Intra arterial Intramuscular Intrathecal Intraorgan Locally in the tissue Other route of infusion 88. Specify what happened to the reserved portion Discarded Cryopreserved for future use Other fate 89. Specify other fate: 92. Specify the site of intraorgan administration of cells: Bone Heart Liver Pancreas Kidneys Brain Lungs Other site 93. Specify other site: 91. Specify other route of infusion: CIBMTR Form 4006 revision 1 (page 7 of 9). Last Updated July, 2016.
8 Cell doses 94. Recipient weight used for this infusion: pounds kilograms 95. Recipient height used for this infusion: inches centimeters Report the total number of cells (not cells per kilogram) contained in the product administered, not corrected for viability 96. Total number of cells administered Known 97. Total number of cells: x Lymphocytes (unselected) administered t applicable 100. CD4+ lymphocytes administered t applicable 102. CD8+ lymphocytes administered t applicable 104. Natural killer cells (NK cells) administered t applicable 99. Total number of cells: x Total number of cells: x Total number of cells: x Total number of cells: x Dendritic cells / tumor cell hybridomas administered t applicable 108. Mesenchymal stromal stem cells (MSCs) administered t applicable 107. Total number of cells: x Total number of cells: x Unspecified mononuclear cells administered t applicable 112. Endothelial progenitor cells administered t applicable 111. Total number of cells: x Total number of cells: x 10 CIBMTR Form 4006 revision 1 (page 8 of 9). Last Updated July, 2016.
9 114. Human umbilical cord perivascular (HUCPV) cells administered t applicable 115. Total number of cells: x Cardiac progenitor cells administered t applicable 118. Islet cells administered t applicable 120. Oligodendrocytes administered t applicable 122. Other cell type administered t applicable 117. Total number of cells: x Total number of cells: x Total number of cells: x Total number of cells: x Specify other cell type: First Name: Last Name: address: Date: / / CIBMTR Form 4006 revision 1 (page 9 of 9). Last Updated July, 2016.
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