Cord Blood Establishing a National Hematopoietic Stem Cell Bank Program (2005) / Chapter Skim
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Pages 301-314
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From page 301... ...
, 25, 79, 9697, 102 Accreditation recommendations, 99102 Standards Committee, 97 accrediting organization, 102 American Red Cross (ARC) , 24, 87, 199 collection site, 100 Cord Blood Program, 80 cord blood banks, 100101 American Society for Histocompatibility transplant facility, 101 and Immunogenetics (ASHI)
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, 45, 209217 Clinical testing and quality control, 248 failures treatable by transplantation of 249 cord blood, 63 Clinical use of cord blood in treating Bone Marrow Donors Worldwide (BMDW) , inherited diseases, examples of 122123, 258 effective, 62 Bone marrow transplantation (BMT)
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, Cord blood lymphocytes, 47 279281 Cord blood storage, 8486, 151156, 179, Current bank status, 7981 204205 collection processes, 8081 costs of, 233234
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infection, 59, 169, 112 273274, 279 permanent unavailability of, 23 protecting confidentiality and privacy of, 116 D transient unavailability of, 23 unavailability of, 23 Danielle Martinez Act, 95 understanding the limitation of their Data sharing, establishing criteria for, 18, rights, 9, 118 138 Duchene muscular dystrophy, 214 Databases, outcomes, 1617, 136 Duke University, 62, 87 De-identification, 118 Carolinas Cord Blood Bank, 48, 80 Detroit donors, 87 Deviations, 101 Differentiated myeloid cells, 215 E Dimethyl sulfoxide (DMSO) , a cryopreservative agent, 81, 85, EMBASE, 143 205 Engraftment Discard rate, 233 lack of, 213 Disclosure, of information regarding long-term, 62 screening and other risks, 112114 Epitopes, serologic, 250 Discount rate, 234 Equity, 235237 Discrepancies, major, clouding the cord Ethical and legal issues, 19, 106119 blood field, 214215 cord blood research, 5, 117118 Diseases, 256257.
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, 5, 78, 11, inventory growth, 17, 137, 198199 1314, 26, 80, 102, 132 Hematological chimerism, 68 Hematological malignancies, 60 G Hematopoietic progenitor cell (HPC) , 17, 13, 5657, 59, 6369, 75, 97, 127, Gastrointestinal disorders, umbilical cord 298 blood in, 68 distribution systems for, 10, 130 Genetic diseases treatable by transplantation donating, 23 of cord blood, 63, 69 ex vivo expansion of cord blood derived bone marrow failures, 63 from, 5859 immune deficiency diseases, 21, 63 homing receptors, 61 metabolic storage disorders, 21, 63 multipotent, 33 Genetic screening, 184 sources of, 5 Good tissue practice (GTP)
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From page 306... ...
system, mismatches, 260 244248 Hispanic donors, 50, 87, 95 allele and haplotype frequencies, 247248 Histocompatibility, 121 antigen presentation function, 244245 HLA Nomenclature Committee, 249 MHC-encoded HLA proteins, 244 Homing receptors, upregulation of, 61 Human transplantation data, 211212 HPCs, developing an outcomes database for Hurler syndrome, umbilical cord blood in, all sources of, 1617, 136 62 Human cellular and tissue-based products (HCT/Ps) , 9293 Human histocompatibility genes, 37, 246 I Human immunodeficiency virus (HIV)
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From page 307... ...
level, 37, 264 Inventory of a National Cord Blood Stem generic or serologic or antigen, 253 Cell Bank Program, 19, 120128 mismatches, 260 costs associated with increasing the at serological broad, 252 inventory, 125126 at serological split, 253 existing cord blood inventory, 122124 Lymphohematopoiesis, 22 Lymphomas, 21
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See National Cord Blood model, 277 Policy Board McCarthy Cord Blood Bank, 87 National Bone Marrow Donor Registry Medical information, promoting the security (NBMDR) , 24 of, 9, 116117 National Cord Blood Bank Program.
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From page 309... ...
See also Potential nonhematopoietic differentiation P from bone marrow cells; Potential nonhematopoietic uses for stem cells Panel on Cost-Effectiveness in Medicine and in cord blood Health, 234 determining usefulness of cord blood in, Parameter values for costs, 232234 216 administrative costs, 234 Nonhematopoietic tissues collection and storage costs, 233234 in clinical specimens, circulating cells cost of transplantation, 234 contribution to, 212 discard rate, 233 differentiation from HSCs, 210211 discount rate, 234 mechanism of HSC-derived initial endowment, 234 incorporation in, 213214
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From page 310... ...
See also National Cord Blood collection of cord blood units, 8283 Policy Board; National inventory screening maternal donors and cord policy blood, 8182 regarding who must provide consent, storage, 8486 cord blood centers needing, 9, 109 transport of cord blood and cell 110 viability, 8384 Polymorphic sequences, 246, 250 Proposed structure of a national program, Potential nonhematopoietic differentiation 15 from bone marrow cells, 209214, Public cord blood banks, 76, 78, 158159, 263264 161, 298 after bone marrow transplantation, 209 Public Cord Blood Tissue Bank, 9495 210 Pulse duplicator bioreactors, 65 human transplantation data, 211212 lack of engraftment reported, 213 mechanism of HSC-derived Q incorporation in nonhematopoietic tissue, 213214 Quality assurance systems, 100 nonhematopoietic differentiation from establishing uniform, 8, 86 Quality of life of patients, 120 HSCs, 210211 prevalence of "transdifferentiation," 213 Potential nonhematopoietic uses for stem R cells in cord blood, 208217 abstract, 208209 Racial and ethnic compositions, 124 determining usefulness of CB in non- of the units in cord blood banks, 8687, hematopoietic repair, 216 167 differences between stem cells in cord Raw data analysis, 146 blood and bone marrow, 216217 Receptor contact residues, 246 evidence, 214215 Recombinant human stem cell factor implications for cell therapy using CB or (rHuSCF) , 61 BM transplantation, 215216 Recommendations, 19 introduction, 209 applying uniform quality standards to all major discrepancies clouding the field, cord blood banks, 8, 103 214215 continuing to conduct outcomes research, 11, 127
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From page 311... ...
INDEX 311 cord blood centers needing policies Registries, 298 regarding who must provide consent, cord blood banks as repositories, 266 9, 109110 international, 258 cord blood donors understanding the optimizing size to find a match, 265266 limitation of their rights, 9, 118 Registry search algorithms, selection of developing a mechanism to make potential HLA matches by, 263264 nonclinical units available for Regression analysis, 83 research use, 1819, 69 Relapse risk, 44 developing an outcomes database for all and graft-versus-leukemia effect, 47 sources of HPCs, 1617, 136 Related donors, 257 establishing a National Cord Blood Relationships that the IOM committee Coordinating Center, 1416, 133 envisions under the governance 134 structure described in its establishing a National Cord Blood recommendations, 135 Policy Board, 14, 132133 Replicative capacities of cells, 35 establishing a national inventory policy, Research, 19, 5674, 266 10, 126127 developing a mechanism to make establishing criteria for data sharing, 18, nonclinical units available for, 18 138 19, 69 establishing FDA licensure of cord blood developing research priorities, 69 units, 8, 94 effective clinical use of cord blood in establishing uniform quality assurance treating inherited diseases, 6263 systems, 8, 86 genetic diseases treatable by establishing uniform standards for cord transplantation of cord blood, 63 blood collection, 8, 83 improving current transplant technology, expanding the current inventory, 11, 5661 127 registries/cord blood banks as funding banks to promote inventory repositories, 266 growth, 17, 137 umbilical cord blood in regenerative identifying a Cord Blood Accrediting medicine, 6469 Organization, 8, 80 Research Involving Human Biological obtaining informed consent prior to Materials: Ethical Issues and Policy labor and delivery, 9, 111 Guidance, 115 promoting the security of medical Results. See also Survey results information, 9, 116117 confirming, 282 providing donors with clear information Rights, of cord blood donors, limiting, 9, about their options, 9, 111 118 providing financial support for infrastructure development, 1718, 138 S Recommended direction for accreditation, 99102 San Diego donors, 87 Scientific Advisory Committee for Organ an accrediting organization, 102 collection site, 100 Transplantation, 133 cord blood banks, 100101 Screening completed prior to storage, 184 191 transplant facility, 101 Recommended structure of a national genetic screening, 184 program, 129139 infectious disease testing, 185187 other exclusions, 188191 national oversight, 132133 structure and governance, 133139 Screening maternal donors, and cord blood, Regenerative potential, 68 8182
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From page 312... ...
, Stroke, 67 67 Stromal cells, 213 clinical use of cord blood in treating, 62 Structure and governance of a national Sibling Cord Blood Program (CHORI) , 80n, program, 133139 81 cord blood bank selection, 138 Sickle cell anemia, clinical use of cord blood finances, 137138 in treating, 62 inventory database and unit selection, Site visits, conducted by the Committee, 136 144145 outcomes data, 136137 Size of identified banks, 80 patient support, 139 Solid-organ transplants, 57, 133 source of transplanted material, 135 Sources of hematopoietic stem cell donors, standards, 139 135, 257258 Sudden acute respiratory syndrome (SARS)
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From page 313... ...
count, 80, 222, 184191 274, 278279, 282 self-reported accreditation, 162 Total number of usable units, 123 storage of the units, 204205 Total units collected, by bank, 165 total units collected, by bank, 165 Toxic liver injury, umbilical cord blood in, tracking units, 177 68 types of banks, 161 Tracking units, 177 units that are not usable for transplant, Transdifferentiation events, 65, 69, 210, 176 214 prevalence of, 213 Transient donor unavailability, 23 T Transient warming events (TWE) , 86 Transit time, 83 T cells, 45, 47, 62 Transplant Amendments Act of 1990, 24 alloreactive, 257 Transplant-related mortality (TRM)
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From page 314... ...
, 78, 9394, 101, 106107, 113114, 117 establishing licensure of cord blood units, 8, 94 regulation of human cell, tissue, and cellular and tissue-based products, 18, 9294, 102, 112n, 136
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