Form 4006 R1.0: Cellular Therapy Infusion
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1 Sequence Number: Date Received: - - CIBMTR Center Number: CIBMTR Research ID: Event date: - - If more than one type of cell therapy product is infused, each product type must be reported separately. Key fields Questions: - 1 Specify donor Autologous Autologous cord blood unit NMDP unrelated cord blood unit NMDP unrelated donor Related donor Related cord blood unit n-nmdp unrelated donor n-nmdp unrelated cord blood unit Other 2 Specify: 3 NMDP cord blood unit ID: 4 NMDP donor ID: 5 n-nmdp unrelated donor ID: (not applicable for related donor) 6 n-nmdp cord blood unit ID: (include related and autologous CBUs) 7 Is there an ISBT DIN number associated with the product? 8 Is the CBU ID also the ISBT DIN number? yes no 9 Specify the ISBT DIN number: 10 Registry or UCB Bank ID 11 Specify other Registry or UCB Bank: 12 Date of birth (donor / infant) 13 Date of birth: (donor / infant) Age (donor / infant) Cellular Therapy Product Identification Questions: Age: (donor / infant) Months (use only if less than 1 year old) years 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 20 Batch number: 21 Lot number 22 Lot number: 23 Where was the cellular therapy product manufactured? Pharmaceutical / biotech company Cell processing laboratory off site Cell processing laboratory at the same center as the product is being infused Other site 24 Specify other site: 25 Specify pharmaceutical / biotech company Specify the institution/company where the cellular product was manufactured: 26 Name: City: The Medical College of Wisconsin, Inc. All rights reserved. Page 1 / 5
2 State: Country: Cell Product Source Questions: Date of cell product collection 28 Date of cell product collection: - - Cell Product Source (1) Questions: What is the tissue source of the cellular product? 30 Specify other tissue source: 31 What is the cell type? 32 Specify other cell type: 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? 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 yes no 44 Lentivirus 45 Retrovirus 46 n-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: The Medical College of Wisconsin, Inc. All rights reserved. Page 2 / 5
3 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 Chimeric Antigen Receptor (CAR) Cell Product Manipulation (1) Questions: Specify details of the CAR construct 59 Specify other construct: 60 Was the product manipulated to recognize a specific target/antigen? 61 Specify target Viral Tumor / cancer antigen Other target Targets specific to viral infections 62 Adenovirus 63 BK virus 64 Cytomegalovirus (CMV) 65 Epstein-Barr virus (EBV) 66 Human herpes virus 6 67 Human Immunodeficiency Virus (HIV) 68 Other virus 69 Specify other virus: Targets specific to tumors 70 Tumor / cancer antigen 71 Specify the target antigen 72 Specify tumor / cancer antigen: 73 Other target 74 Specify other target: 75 Other cell manipulation 76 Specify other cell manipulation: Cell Product Analysis Questions: Was transfection efficiency done? (genetically engineered cells) 78 Date: Transfection efficiency: % 80 Was transfection efficiency target achieved? 81 Viability of cells Done t done 82 Date: Viability of cells: % The Medical College of Wisconsin, Inc. All rights reserved. Page 3 / 5
4 84 Method of testing cell viability 7-AAD Propidium iodide Trypan blue Other method 85 Specify other method: 86 Date of this product infusion: Was the entire volume of product infused? 88 Specify what happened to the reserved portion Discarded Cryopreserved for future use Other fate 89 Specify other fate: 90 Specify the route of product infusion 91 Specify other route of infusion: 92 Specify the site of intraorgan administration of cells Cell doses 93 Specify other site: 94 Recipient weight used for this infusion: pounds kilograms 95 Recipient height used for this infusion: inches centimeters Product Infusion Questions: 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 97 Total number of cells: 98 Lymphocytes (unselected) administered t Applicable 99 Total number of cells: 100 CD4+ lymphocytes administered t Applicable 101 Total number of cells: 102 CD8+ lymphocytes administered t Applicable 103 Total number of cells: 104 Natural killer cells (NK cells) administered t Applicable 105 Total number of cells: 106 Dendritic cells / tumor cell hybridomas administered t Applicable 107 Total number of cells: 108 Mesenchymal stromal stem cells (MSCs) administered t Applicable 109 Total number of cells: 110 Unspecified mononuclear cells administered t Applicable 111 Total number of cells: 112 Endothelial progenitor cells administered t Applicable 113 Total number of cells: 114 Human umbilical cord perivascular (HUCPV) cells administered t Applicable 115 Total number of cells: 116 Cardiac progenitor cells administered t Applicable 117 Total number of cells: 118 Islet cells administered t Applicable 119 Total number of cells: 120 Oligodendrocytes administered t Applicable 121 Total number of cells: The Medical College of Wisconsin, Inc. All rights reserved. Page 4 / 5
5 122 Other cell type administered First Name: t Applicable 123 Total number of cells: 124 Specify other cell type: address: Last Name: Date: The Medical College of Wisconsin, Inc. All rights reserved. Page 5 / 5
4006: Cellular Therapy Infusion
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. If
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