National Academies Press: OpenBook
« Previous: Glossary
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

INDEX

A

Accessing units, 49, 87–92

information flow, 87–90

patient support in the search and transplant process, 91–92

physician support in the search and transplant process, 91

probability of finding a donor, 90–91

Accreditation, 96–102

American Association of Blood Banks, 96–97

Foundation for the Accreditation of Cellular Therapy, 97–99

new organization, 102

NMDP standards, 99

self-reported, 162

Accreditation recommendations, 99–102

accrediting organization, 102

collection site, 100

cord blood banks, 100–101

transplant facility, 101

Administrative costs, 234

Adverse events, 101

Advisory Council on Cord Blood Donation, 95

African American donors, 37, 50, 87, 95, 124, 248, 258

African American recipients, 235–236

Algorithm for selection, of bone marrow versus umbilical cord blood, 89–90

Allele frequencies, 247–248

Allele levels, 254

Alleles, 297

identified at each HLA locus, 245

which encode specific HLA proteins (or antigens), 255

Allocation systems, 280

Allogeneic transplantation, 21, 38–43, 297

indications for stem cell support, 39–40

outcomes of transplantation of HPCs from unrelated donors, 38–43

Alloreactive T cells, 257

Allorecognition, 257

American Association of Blood Banks (AABB), 25, 79, 96–97, 102

Standards Committee, 97

American Red Cross (ARC), 24, 87, 199

Cord Blood Program, 80

American Society for Histocompatibility and Immunogenetics (ASHI), 248

Standards for HLA Testing, 249

American Society of Blood and Marrow Transplantation (ASBMT), 97–98

Anticoagulants

citrate dextrose solution, formula A (ACD-A), 205

citrate-phosphate-dextrose (CPD), 81, 205

isotonic, 82

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

Antigen presentation function, 244–245

Aplastic anemia, 21

Asian American donors, 50, 87, 248

standards for, 98

Aspergillis, 59

Aspilt@, 251

Australian donors, standards for, 98

Autoimmune diseases, treating, 57

Autologous transplantation, 43–44, 297

indications for stem cell support, 39–40

Available units, across all banks, 166

B

Banks. See Cord blood banks

Bar coding, 84, 177

Beta thalessemia, clinical use of cord blood in treating, 62

Biological characteristics, of umbilical cord blood, 33–38

“Biological life insurance,” 78

Biological Response Modifiers Advisory Committee (BRMAC), 93–94

Bone marrow (BM), 45, 209–217

failures treatable by transplantation of cord blood, 63

Bone Marrow Donors Worldwide (BMDW), 122–123, 258

Bone marrow transplantation (BMT), 47, 172

aftermath of, 209–210

Brain injury, 67–68

non-stroke-related brain damage, 67–68

stroke, 67

umbilical cord blood in, 67–68

C

California donors, 87

Canadian donors, standards for, 98

Cardiac repair, umbilical cord blood in, 65–66

Cardiac stem cell precursors, 66

Cardiomyocytes, 212–213

Carolinas Cord Blood Bank, 48, 80

Caucasian donors, 37, 50, 87, 236, 238, 248

Caucasian recipients, 235

CD34* cell counts, 40, 50, 58, 61, 67, 82–83, 93–94, 171

Cell viability, 171

transport of cord blood and, 83–84

Cellular Therapies Standards Program Unit, 96

Center for International Blood and Marrow Transplant Research (CIBMTR), 34–35

Centers for Disease Control (CDC), Health Information for International Travel, 191

Central nervous system disease, umbilical cord blood in, 66

Chimerism, 58, 212, 297

double, 59

hematological, 68

Circulating cells, contribution to nonhematopoietic tissues in clinical specimens, 212

Citrate dextrose solution, formula A (ACD-A), an anticoagulant, 205

Citrate-phosphate-dextrose (CPD), an anticoagulant, 81, 205

Clinical Laboratory Improvement Amendments (CLIA), 248

Clinical testing and quality control, 248–249

Clinical use of cord blood in treating inherited diseases, examples of effective, 62

Colitis, ulcerative, 68

Collection of cord blood units, 82–83, 100, 151–156, 179

centers for, 297

costs, 233–234

processes used, 80–81, 179

sites for, 100

Colony-forming units (CFUs), 84

granulocyte-macrophage (CFU-GM), 83

megakaryocyte (CFU-M), 33

mixed (CFU-MIX), 78–79

Commissioned papers, 146, 208–271

Committed progenitor cells, 33

Committee on Establishing a National Cord Blood Stem Cell Bank Program, 6, 30, 79, 90

meetings, 146–147

site visits conducted by, 145

Confidentiality, of donors, protecting, 116

Confirmatory typing (CT), 197, 263

Congenital adrenal hyperplasia (CAH), 190

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

Consent practices. See also Informed consent of donors

for agencies currently involved with cord blood, 108

Consolidated Appropriation Act, 5

Cord blood (CB)

consent practices for agencies currently involved with, 108, 209–217

major components in the process of collection, banking, and transplantation, 77

research in, 5, 117–118

searches for, 25

Cord Blood Accrediting Organization, 83, 86

identifying, 8, 80

Cord Blood Banking and Transplantation (COBLT) study, 1–2, 10, 14, 40, 43, 48–50, 133, 233, 273–276

eligibility for, 48–50

stratification variables for, 49

Cord blood banks (CBBs), 100–101, 297.

See also Private cord blood banks;

Public cord blood banks;

individual cord blood banks

applying uniform quality standards to all, 297

cost recovery by, 125

currently collecting units, 166

defined, 76–79

developing, 23–24

funding to promote inventory growth, 17, 137, 198–199

options for, 78

reputation of, 123

responding, 160

selecting, 138

that offer both private and public, 161

in the United States, list of, 24n

Cord Blood Center. See National Cord Blood Coordinating Center

Cord blood collection, establishing uniform standards for, 8, 83

Cord Blood Coordinating Center. See National Cord Blood Coordinating Center

Cord blood donors. See Donors

Cord Blood Family Trust, 80–81

Cord blood lymphocytes, 47

Cord blood storage, 84–86, 151–156, 179, 204–205

costs of, 233–234

methods, 81

motives for, 76

storage length, 233

Cord blood (CB) transplantation, 38–50, 67, 209, 297

after nonmyeloablative therapy, 57–58

allogeneic transplantation, 38–43

autologous transplantation, 43–44

graft versus host disease, 45–47

outcomes of transplantation of HPCs from related donors, 44–45

Cord blood units (CBUs), 297

collecting, 82–83

establishing FDA licensure of, 8, 94

Coriell Institute for Medical Research, 95

Cost-benefit of increasing cord blood inventory levels, 221–241

conclusion, 239

equity, 235–237

incremental cost-effectiveness, 235

introduction, 221–222

patient survival time, 222–231

sensitivity analyses, 237–238

Cost estimates, 234–235

by inventory level, 235

Cost model, 231–232

parameters, 233

Cost per life year gained, as a function of cord inventory, 236

Costs, 196–197, 231–235

associated with increasing the inventory, 125–126

recovering, 125

of transplantation, 234

of typing, 254

Creutzfeldt-Jakob disease (CJF), 191

Criteria

for data sharing, establishing, 18, 138

to determine which units are for transplant, 172–175

to determine which units are suitable for banking, 168–171

Crohn’s disease, 68

Cryobanks International, Inc., 80

Cryopreservation, 85

Cryopreservative agents, dimethyl sulfoxide, 81, 85, 205

Cumulative proportion alive (engrafted), 279–281

Current bank status, 79–81

collection processes, 80–81

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

size of identified banks, 80

storage methods, 81

Current good tissue practice (cGTP), 92

Current inventory, expanding, 11, 127

Current transplant technology

approaches to accelerate immune recovery, 59

coinfusion of mesenchymal stem cells, 60–61

cord blood transplantation after nonmyeloablative therapy, 57–58

ex vivo expansion of cord blood derived from hematopoietic progenitor cells, 58–59

improving, 56–61

multiple cord blood unit transplantation, 59–60

upregulation of homing receptors, 61

Cytomegalovirus (CMV) infection, 59, 169, 273–274, 279

D

Danielle Martinez Act, 95

Data sharing, establishing criteria for, 18, 138

Databases, outcomes, 16–17, 136

De-identification, 118

Detroit donors, 87

Deviations, 101

Differentiated myeloid cells, 215

Dimethyl sulfoxide (DMSO), a cryopreservative agent, 81, 85, 205

Discard rate, 233

Disclosure, of information regarding screening and other risks, 112–114

Discount rate, 234

Discrepancies, major, clouding the cord blood field, 214–215

Diseases, 256–257.

See also Autoimmune diseases;

Central nervous system disease;

Genetic diseases treatable by transplantation of cord blood;

Immune deficiency diseases;

Infectious disease;

Inherited diseases

Distribution systems, for hematopoietic progenitor cells, 10, 130

DNA-based testing, 114, 243, 250–251, 254–256, 261

Donor cell contribution to nonhematopoietic tissues after whole bone marrow transplantation, in animal models, 210

Donor identification, removal of, 117

Donor records, maintenance of, 114–117

Donor selection, 258–264

defining a “match,” 258–259

defining a mismatch, 260

HLA matching to optimize outcome in marrow transplantation, 36, 260

HLA testing at recruitment and at the time of donor selection, 261–263

selection of potential HLA matches by registry search algorithms, 263–264

Donors, 106

clarifying potential options and outcomes of donation for, 9, 111–112

permanent unavailability of, 23

protecting confidentiality and privacy of, 116

transient unavailability of, 23

unavailability of, 23

understanding the limitation of their rights, 9, 118

Duchene muscular dystrophy, 214

Duke University, 62, 87

Carolinas Cord Blood Bank, 48, 80

E

EMBASE, 143

Engraftment

lack of, 213

long-term, 62

Epitopes, serologic, 250

Equity, 235–237

Ethical and legal issues, 19, 106–119

cord blood research, 5, 117–118

disclosure of information regarding screening and other risks, 112–114

informed consent of donors, 107–112

maintenance of donor records and patient privacy, 114–117

European donors, 22

standards for, 98

European Federation for Immunogenetics (EFI), 248

European Group for Blood and Marrow Transplantation (EBMT), 41n, 172

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

European Research Project on Cord Blood Transplantation (Eurocord), 35, 42

registry, 44–45

Exclusion criteria, 180–183

Existing cord blood inventory, 122–124

likelihood of finding a match, 123–124

racial and ethnic representation, 124

total number of usable units, 123

Expanded Access Protocol, 50

Extended haplotypes, 247

F

Fanconi anemia, umbilical cord blood in, 62

Federal Advisory Committee Act, 14, 133

Federal Register, 14, 133

Financial support, for infrastructure development, providing, 17–18, 137–138

Findings, number of new units needed, 137

Florida Center for Universal Research to Eradicate Disease, 96

Florida donors, 87, 94–99

Florida Public Health Provision, 95

Follow-up, on neonatal health status, 200

Foundation for the Accreditation of Cellular Therapy (FACT), 25, 79, 97–99, 102, 172

banks meeting standards of, 50

standards of, 99

Funding, of cord blood banks to promote inventory growth, 17, 137, 198–199

G

Gastrointestinal disorders, umbilical cord blood in, 68

Genetic diseases treatable by transplantation of cord blood, 63, 69

bone marrow failures, 63

immune deficiency diseases, 21, 63

metabolic storage disorders, 21, 63

Genetic screening, 184

Good tissue practice (GTP), 92

Government regulations, 92–96

FDA regulation of human cell, tissue, and cellular and tissue-based products, 92–94

state-legislated programs, 94–96

Graft-versus-host disease (GVHD), 2, 21–22, 24, 35–36, 38, 41–47, 56–60, 213, 298

preventing, 44

relapse and graft-versus-leukemia effect, 47

Graft-versus-leukemia (GVL) effect, 47

relapse and, 47

Granulocyte-macrophage colony-forming units (CFU-GM), 83

Growth. See Inventory growth

H

Haemolysis, elevated liver enzymes, low platelets (HELLP), 181, 183, 206

Haplotypes, 23n, 37, 247, 298

extended, 247

frequencies of, 247–248

predicting, 247

uncommon, 264

Health Care Financing Administration (HCFA), 249

Health care payment systems, 17

Health insurance, 113

Health Insurance Portability and Accountability Act (HIPAA)

de-identification rules under, 117–118

Privacy Rule of, 115

Health Resources and Services Administration (HRSA), 5, 7–8, 11, 13–14, 26, 80, 102, 132

Hematological chimerism, 68

Hematological malignancies, 60

Hematopoietic progenitor cell (HPC), 1–7, 13, 56–57, 59, 63–69, 75, 97, 127, 298

distribution systems for, 10, 130

donating, 23

ex vivo expansion of cord blood derived from, 58–59

homing receptors, 61

multipotent, 33

sources of, 5

Hematopoietic progenitor cell (HPC) transplantation

continued evolution of, 120

experimental, 106–107

facilities for, 98

therapeutic promise of, 20–22, 26, 38, 94, 121

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

Hematopoietic stem cell (HSC), 209–217

formation of multiple peripheral blood cells from multipotent, 34

Hematopoietic stem cell (HSC) transplantation, 5, 33–55

biological characteristics of umbilical cord blood, 33–38

cord blood transplantation, 38–50

Hemoglobinopathies, 169, 298

Hepatitis B core antibody (hbcAb), 171

Hepatitis B virus (HBV), 85, 169

Hepatitis C virus (HCV), 169, 190

Hepatocytes, marrow-derived, 68

Hespan, 85

High resolution (HR) level, 27, 254

mismatches, 260

Hispanic donors, 50, 87, 95

Histocompatibility, 121

HLA Nomenclature Committee, 249

Homing receptors, upregulation of, 61

HPCs, developing an outcomes database for all sources of, 16–17, 136

Human cellular and tissue-based products (HCT/Ps), 92–93

Human histocompatibility genes, 37, 246

Human immunodeficiency virus (HIV), 169, 190

Human leukocyte antigen (HLA), 2–3, 21, 36, 244–266, 298

alleles, 246

allorecognition, 257

antigens, 21

assignment of nomenclature, 249

in disease and transplantation, 256–257

disparities among, 57, 91, 125, 266

genes, 245

haplotypes, 246–247

and HLA matching, 10, 36

matched units, 60, 91, 123–124, 127–128, 260, 276–281

mismatched units, 3, 10, 42, 56, 120, 125, 137, 266, 276, 279

as molecules, 242–243, 249–252

responsibilities of banks regarding, 100

testing, 117

testing at recruitment and at the time of

donor selection, 261–263

typing, 6–7, 25, 34, 36–37, 43, 59, 75–76, 90, 136, 246–256

typing assignments carried by volunteer donors on registries, 16, 261

Human leukocyte antigen (HLA) overview, 242–266

donor selection, 258–264

key observations on HLA and hemotopoietic stem cell transplantation, 242–243

probability of finding an allele match for HLA loci, 264–266

research, 266

sources of hematopoietic stem cell donors, 257–258

testing methodology, 249–251

testing resolution, 252–254

tissue typing, 248–256

Human leukocyte antigen (HLA) system, 244–248

allele and haplotype frequencies, 247–248

antigen presentation function, 244–245

MHC-encoded HLA proteins, 244

Human transplantation data, 211–212

Hurler syndrome, umbilical cord blood in, 62

I

Illinois donors, 95

Immune deficiency diseases, 21

treatable by transplantation of cord blood, 63

Immune recovery, approaches to accelerate, 59

Immunosuppression, 22, 298

Incremental cost-effectiveness, 235

Infectious disease, 22, 169

testing for, 180–183, 185–187

Informatics, 178

Information

about donors’ options, providing clear, 9, 111

flow of, 87–90

medical, promoting the security of, 9, 116–117

regarding screening and other risks, disclosure of, 112–114

Information Technology Working Group, 258

Informed consent of donors, 5, 107–112

clarifying potential options and outcomes of donation, 111–112

obtaining prior to labor and delivery, 9, 111

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

requirements for consent, 107–110

standards for obtaining, 112

timing of consent, 110–111

Infrastructure development, providing financial support for, 17–18, 138

Inherited diseases

beta thalessemia, 62

effective clinical use of cord blood in treating, 62–63

Fanconi anemia, 62

Hurler syndrome, 62

osteopetrosis, 62

severe combined immunodeficiency, 62

sickle cell anemia, 62

umbilical cord blood as effector cells, 63

Wiskott-Aldrich syndrome, 62

Institute of Medicine (IOM), 1, 5–6, 27, 30, 79, 90, 120, 122n, 130, 133, 233

Statistical Report, 229

Institutional review boards (IRBs), 112, 117, 172

Intermediate resolution level, 171, 253–254

Internal audits, 101

International Bone Marrow Transplant Registry (IBMTR) scale, 34, 45, 225, 229, 274

International Cord Blood Transplant Registry (ICBTR), 34

International Histocompatibility Workshops, 249

International registries and cord blood banks, 258

International Society for Cellular Therapy (ISCT), 97

International Society of Blood Transfusion (ISBT), 177

International Society of Hematotherapy and Graft Engineering (ISHAGE), 98

Interstate commerce, applicability of, 92

Inventory, 150–151

database and unit selection, 136

initial, 234

Inventory growth

expanding the current, 11, 127

funding of cord blood banks to promote, 17, 137, 198–199

Inventory of a National Cord Blood Stem Cell Bank Program, 19, 120–128

costs associated with increasing the inventory, 125–126

existing cord blood inventory, 122–124

practical considerations, 124–126

recommendations, 126–128

summary, 128

Inventory policy. See also National Cord Blood Policy Board

establishing, 10, 126–127

Investigational new drugs (INDs), 94, 101, 116

applications for, 8, 106–107, 117

Isotonic anticoagulants, 82

J

Japanese Cord Blood Banking Network (JCBBN), 35

Japanese donors, 22

Joint Accreditation Committee ISCT EBMT (JACIE), 172

Joint Commission for Accreditation of Healthcare Organizations (JCAHO), 249

K

Karmanos Cancer Institute, 87

L

Labor and delivery, obtaining informed consent prior to, 9, 111

Legal issues. See Ethical and legal issues

Legislation, 27.

See also individual acts

Leukemia, 21.

See also Graft-versus-leukemia effect

Life years gained, 229–231

from marrow and cord transplantation, 230

total, for transplant candidates, 231

Lifebank USA, 80

LifeCord, 79

Limitation, of the rights of cord blood donors, 9, 118

Literature search, 143–144

Low resolution (LR) level, 37, 264

generic or serologic or antigen, 253

mismatches, 260

at serological broad, 252

at serological split, 253

Lymphohematopoiesis, 22

Lymphomas, 21

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

M

Major histocompatibility complex (MHC), 244–246

Maryland donors, 95

Massachusetts donors, 87

Match probabilities, 222–224, 259

for pediatric patients, 224

by race, 237

searching for, 22–23, 156–158

Matches

defined, 258–259

likelihood of finding, 123–124

Maximum likelihood estimates, standard errors, and probabilities main effects model, 277

McCarthy Cord Blood Bank, 87

Medical information, promoting the security of, 9, 116–117

Medium-chain acyl-CoA dehydrogenase (MCAD), 190

Medline, 143

Megakaryocyte colony-forming units (CFU-M), 33

Mesenchymal stem cells (MSCs), 67

coinfusion of, 60–61

Metabolic storage disorders, treatable by transplantation of cord blood, 21, 63

Methodologies, 143–148

commissioned papers, 146

committee meetings, 146–147

literature search, 143–144

raw data analysis, 146

site visits, 144–145

survey, 145

MHC-encoded HLA proteins, 244

Milano Cord Blood Bank, 233

Minority consent, 109

Mismatches

defined, 260

high resolution, 260

low resolution, 260

major, 260

minor, 260

“permissive,” 260

Mixed colony-forming units (CFU-MIX), 78–79

Mixed-type banks, 78–79, 161, 298

MSC-like cells, 65.

See also Mesenchymal stem cells

Multiple cord blood unit transplantation, 59–60

Multipotent hematopoietic stem cells, formation of multiple peripheral blood cells from, 34

Muscular dystrophy, 214

Myeloid cells, 214

differentiated, 215

N

National Bioethics Advisory Commission, 115

National Board. See National Cord Blood Policy Board

National Bone Marrow Donor Registry (NBMDR), 24

National Cord Blood Bank Program. See National Cord Blood Stem Cell Bank Program

National Cord Blood Coordinating Center, 13, 18, 121, 133–139

establishing, 14–16, 133–134

needing policies regarding who must provide consent, 9, 109–110

National Cord Blood Policy Board, 13, 16, 18–19, 69, 122, 132–136, 138

establishing, 14, 132–133

National Cord Blood Stem Cell Bank Program, 2, 4, 8, 11–14, 80, 102–103, 121, 129–139

as envisioned by the Institute of Medicine committee, 132

inventory of, 19, 120–128

key functions, 13

summary of recommendations for establishing, 19

National Heart, Lung, and Blood Institute (NHLBI), 40, 273–276

analysis of the cord blood data from, 273–282

Cord Blood Banking and Transplantation study, 1–2, 10, 14, 40, 43, 48–50, 133, 233, 273

National Institutes of Health (NIH), 11, 27, 69

Office of Human Research Protection, 115–116

National inventory policy. See also National Cord Blood Policy Board

establishing, 10, 126–127

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

National Marrow Donor Program (NMDP), 1, 10, 12, 14, 24, 26, 40, 79, 86, 91, 99, 102, 130–131, 133, 135, 172, 197, 222, 225, 243, 248–249, 256, 258, 260, 263–264, 273–274

analysis of the cord blood data from, 273–282

banks approved by, 49

standards, 99

views on an ideal National Stem Cell Cord Blood Bank program from, 28

National oversight, 132–133

Native American donors, 87, 95

Natural killer (NK) cells, 47, 63, 257

Neonatal health status follow-up, 200–203

Neoplastic transformation, 215

NetCord, 25, 98, 102

banks meeting standards of, 50

Neural cell phenotypes, 66

Neutrophil recovery, 38, 40, 60–61

New Jersey Cord Blood Bank, 95

New Jersey donors, 95–96

New Mexico donors, 96

New York Blood Center (NYBC), 1, 10, 24, 27, 40, 49, 62, 91, 93, 273–276

analysis of the cord blood data from, 273–282

National Cord Blood Program of, 1, 13, 26–27, 80, 102, 132, 274

views on an ideal National Stem Cell Cord Blood Bank program from, 28

Non-Caucasian donors, 22–23, 236, 238, 276

Non-stroke-related brain damage, 67–68

Nonclinical units, for research use, developing a mechanism to make available, 18–19, 69

Nonhematopoietic applications, 65

Nonhematopoietic disease, 214

Nonhematopoietic repair. See also Potential nonhematopoietic differentiation from bone marrow cells;

Potential nonhematopoietic uses for stem cells in cord blood

determining usefulness of cord blood in, 216

Nonhematopoietic tissues

in clinical specimens, circulating cells contribution to, 212

differentiation from HSCs, 210–211

mechanism of HSC-derived incorporation in, 213–214

Nonmyeloablative therapy, 58

preparatory regimens, 62

North American Task Force (NATF), 98–99

Numbers of annual transplants, by cord blood inventory level, projected, 228

Numbers of units

collected, stored, and transplanted, 163–164

collected and shipped, 191–195

O

Office of Human Research Protection (OHRP), 115–116

Oklahoma donors, 95

Optimizing registry size, to find a match, 265–266

Options, providing donors with clear information about, 9, 111

Organ Procurement and Transplantation: Assessing Current Policies and the Potential of the DHHS Final Rule, 130

Organ Procurement Transplantation Network, 133

Organ Transplants Amendment Act of 1988, 24

Osteopetrosis, clinical use of cord blood in treating, 62

Outcomes data, 4, 136–137

developing for all sources of HPCs, 16–17, 136

Outcomes of transplantation of HPCs

continuing to conduct research on, 11, 127

from an unrelated donor, 38–41

from related donors, 44–45

from unrelated adult donors, 41–43

P

Panel on Cost-Effectiveness in Medicine and Health, 234

Parameter values for costs, 232–234

administrative costs, 234

collection and storage costs, 233–234

cost of transplantation, 234

discard rate, 233

discount rate, 234

initial endowment, 234

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

initial inventory, 234

storage length, 233

Paternal objections, 107, 109

Patient survival time, 222–231

life years gained, 229–231

match probabilities, 222–224

numbers of transplants, 225–229

Patients

maintaining privacy of, 114–117

in the search and transplant process, 91–92

supporting, 139

Pentaspan, 85

“Permissive” mismatches, 260

Phenotypes, neural cell, 66

Phenylketonuria (PKU), 190

Physician support, in the search and transplant process, 91

Policies. See also National Cord Blood Policy Board;

National inventory policy

regarding who must provide consent, cord blood centers needing, 9, 109–110

Polymorphic sequences, 246, 250

Potential nonhematopoietic differentiation from bone marrow cells, 209–214, 263–264

after bone marrow transplantation, 209–2210

human transplantation data, 211–212

lack of engraftment reported, 213

mechanism of HSC-derived incorporation in nonhematopoietic tissue, 213–214

nonhematopoietic differentiation from HSCs, 210–211

prevalence of “transdifferentiation,” 213

Potential nonhematopoietic uses for stem cells in cord blood, 208–217

abstract, 208–209

determining usefulness of CB in nonhematopoietic repair, 216

differences between stem cells in cord blood and bone marrow, 216–217

evidence, 214–215

implications for cell therapy using CB or BM transplantation, 215–216

introduction, 209

major discrepancies clouding the field, 214–215

summary, conclusions, and recommendations, 217

Pregnant women, 9, 106

respect for autonomous choice by, 110

PreMedline, 143

Privacy, of donors, protecting, 116

Privacy Rule, of the Health Insurance Portability and Accountability Act, 115

Private cord blood banks, 78, 103, 158, 161, 298

Probabilities

of finding a donor, 90–91

of finding an allele match for HLA loci, 264–266

optimizing registry size to find a match, 265–266

Processing procedures, 81–86

collection of cord blood units, 82–83

screening maternal donors and cord blood, 81–82

storage, 84–86

transport of cord blood and cell viability, 83–84

Proposed structure of a national program, 15

Public cord blood banks, 76, 78, 158–159, 161, 298

Public Cord Blood Tissue Bank, 94–95

Pulse duplicator bioreactors, 65

Q

Quality assurance systems, 100

establishing uniform, 8, 86

Quality of life of patients, 120

R

Racial and ethnic compositions, 124

of the units in cord blood banks, 86–87, 167

Raw data analysis, 146

Receptor contact residues, 246

Recombinant human stem cell factor (rHuSCF), 61

Recommendations, 19

applying uniform quality standards to all cord blood banks, 8, 103

continuing to conduct outcomes research, 11, 127

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

cord blood centers needing policies regarding who must provide consent, 9, 109–110

cord blood donors understanding the limitation of their rights, 9, 118

developing a mechanism to make nonclinical units available for research use, 18–19, 69

developing an outcomes database for all sources of HPCs, 16–17, 136

establishing a National Cord Blood Coordinating Center, 14–16, 133–134

establishing a National Cord Blood Policy Board, 14, 132–133

establishing a national inventory policy, 10, 126–127

establishing criteria for data sharing, 18, 138

establishing FDA licensure of cord blood units, 8, 94

establishing uniform quality assurance systems, 8, 86

establishing uniform standards for cord blood collection, 8, 83

expanding the current inventory, 11, 127

funding banks to promote inventory growth, 17, 137

identifying a Cord Blood Accrediting Organization, 8, 80

obtaining informed consent prior to labor and delivery, 9, 111

promoting the security of medical information, 9, 116–117

providing donors with clear information about their options, 9, 111

providing financial support for infrastructure development, 17–18, 138

Recommended direction for accreditation, 99–102

an accrediting organization, 102

collection site, 100

cord blood banks, 100–101

transplant facility, 101

Recommended structure of a national program, 129–139

national oversight, 132–133

structure and governance, 133–139

Regenerative potential, 68

Registries, 298

cord blood banks as repositories, 266

international, 258

optimizing size to find a match, 265–266

Registry search algorithms, selection of potential HLA matches by, 263–264

Regression analysis, 83

Relapse risk, 44

and graft-versus-leukemia effect, 47

Related donors, 257

Relationships that the IOM committee envisions under the governance structure described in its recommendations, 135

Replicative capacities of cells, 35

Research, 19, 56–74, 266

developing a mechanism to make nonclinical units available for, 18–19, 69

developing research priorities, 69

effective clinical use of cord blood in treating inherited diseases, 62–63

genetic diseases treatable by transplantation of cord blood, 63

improving current transplant technology, 56–61

registries/cord blood banks as repositories, 266

umbilical cord blood in regenerative medicine, 64–69

Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, 115

Results. See also Survey results

confirming, 282

Rights, of cord blood donors, limiting, 9, 118

S

San Diego donors, 87

Scientific Advisory Committee for Organ Transplantation, 133

Screening completed prior to storage, 184–191

genetic screening, 184

infectious disease testing, 185–187

other exclusions, 188–191

Screening maternal donors, and cord blood, 81–82

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

Search strategy for patients, 227

algorithms for, 25, 263–264

Security, of medical information, promoting, 9, 116–117

Selection of potential HLA matches by registry search algorithms, 263–264

Self-reported accreditation, 162

Sensitivity analyses, 237–238

Sequence specific, 249

Serologic epitopes, 250

Serologic typing, 243, 249–250, 252, 255–256

defining antigens and DNA-defined types, relationships between, 253

Severe combined immunodeficiency (SCID), 67

clinical use of cord blood in treating, 62

Sibling Cord Blood Program (CHORI), 80n, 81

Sickle cell anemia, clinical use of cord blood in treating, 62

Site visits, conducted by the Committee, 144–145

Size of identified banks, 80

Solid-organ transplants, 57, 133

Sources of hematopoietic stem cell donors, 135, 257–258

international registries and cord blood banks, 258

related donors, 257

SouthEastern Organ Procurement Foundation (SEOPF), 249

Spinal cord injury, umbilical cord blood in, 66–67

St. Louis Cord Blood Bank, 80

Standards, 139

for cord blood collection, establishing uniform, 8, 83

for obtaining informed consent of donors, 112

Standards for Blood Banks and Transfusion Services, 96

Standards for Cellular Therapy Product Services, 96

Standards for Cord Blood Services, 96

Standards for Hematopoietic Progenitor Cells, 96

Standards for HLA Testing, 249

State-legislated programs, 94–96

Danielle Martinez Act, 95

Statistical Report, 229, 273–282

Status of current banks, 79–81

Stem cells in cord blood and bone marrow, 298–299

differences between, 216–217

potential nonhematopoietic uses for, 208–217

StemCyte International Cord Blood Banks, 80–81

Steps in donor selection, 262

Stigmatization, 113

Storage containers, for cryopreservation of cord blood units, example of, 84

Storage of cord blood units. See Cord blood storage

Stroke, 67

Stromal cells, 213

Structure and governance of a national program, 133–139

cord blood bank selection, 138

finances, 137–138

inventory database and unit selection, 136

outcomes data, 136–137

patient support, 139

source of transplanted material, 135

standards, 139

Sudden acute respiratory syndrome (SARS), 191

Summaries

of current research, 64

of HLA matches, 264–265

of recommendations for establishing a National Cord Blood Stem Cell Bank program, 19

of statistics cell dose, age, and HLA mismatch, 281

of statistics predictors by outcomes, 275

Survey, 145, 149–159

status of current banks, 79–81

Survey results, 160–205

available units across all banks, 166

banks that responded, 160

banks which are currently collecting units, 166

collection process, 179

costs, 196–197

criteria to determine which units are for transplant, 172–175

criteria to determine which units are suitable for banking, 168–171

exclusion criteria, 180–183

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

funding of public banks, 198–199

informatics, 178

neonatal health status follow-up, 200–203

numbers of units collected, stored, and transplanted, 163–164

numbers of units collected and shipped, 191–195

racial makeup of inventory, 167

screening completed prior to storage, 184–191

self-reported accreditation, 162

storage of the units, 204–205

total units collected, by bank, 165

tracking units, 177

types of banks, 161

units that are not usable for transplant, 176

T

T cells, 45, 47, 62

alloreactive, 257

receptor contact residues, 246

recognition of, 245

suppressing responses of, 61

T lymphocytes, 244, 257

T-regulatory cells, 59

Testing methodology, 249–251

DNA-based methods, 250–251

impact of allele discovery and genotype summarization on, 254–255

serology, 249–250

Testing resolution, 252–254

allele level, 254

high-resolution level, 254

intermediate resolution level, 253–254

low resolution at serological broad, 252

low resolution at serological split, 253

low resolution (generic or serologic or antigen) level, 253

Texas Cord Blood Bank, 96

Texas donors, 95

Thawing, 101

Timing of consent, 110–111

Tissue typing, 248–256

clinical testing and quality control, 248–249

comparison of typing methods, 252

correlation of DNA-based and serologic types, 255–256

cost of typing, 254

HLA assignments—nomenclature, 249

impact of allele discovery and genotype summarization on test interpretation, 254–255

testing methodology, 249–251

testing resolution, 252–254

Total body irradiation/cytokine (TBI/Cy), 49

Total nucleated cell (TNC) count, 80, 222, 274, 278–279, 282

Total number of usable units, 123

Total units collected, by bank, 165

Toxic liver injury, umbilical cord blood in, 68

Tracking units, 177

Transdifferentiation events, 65, 69, 210, 214

prevalence of, 213

Transient donor unavailability, 23

Transient warming events (TWE), 86

Transit time, 83

Transplant Amendments Act of 1990, 24

Transplant-related mortality (TRM), 278

Transplants (tx)

centers for, 261, 299

facilities for, 101

numbers of, 225–229

solid organ, 57, 133

Transport of cord blood, and cell viability, 83–84

Types of banks, 161

banks that offer both private and public, 161

mixed, 78–79, 161

private banks, 161

public banks, 161

Typing methods, comparison of, 252

U

Ulcerative colitis, 68

Umbilical cord blood (UCB), 299

biological characteristics of, 33–38

as effector cells, 63

Umbilical Cord Blood Banking Act, 96

Umbilical cord blood (UCB) banks and banking, 19, 75–105.

See also Cord blood banks

accessing units, 87–92

accreditation, 96–102

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×

definition of a cord blood bank, 76–79

government regulations, 92–96

private banks, 103

processing procedures, 81–86

racial and ethnic compositions of the units in cord blood banks, 86–87

status of current banks, 79–81

Umbilical cord blood (UCB) in regenerative medicine, 64–69

brain injury, 67–68

cardiac repair, 65–66

central nervous system disease, 66

gastrointestinal disorders, 68

gene therapy, 69

spinal cord injury, 66–67

toxic liver injury, 68

Unavailability, of donors, 23

Uniform quality assurance systems, establishing, 8, 86

Uniform standards for cord blood collection, establishing, 8, 83

United Network for Organ Sharing (UNOS), 249

United States Pharmacopeia (USP) grading, 205

University of California, Los Angeles (UCLA), 48

Upregulation, of homing receptors, 61

U.S. Congress, 27

U.S. Department of Health and Human Services (DHHS), 4, 7, 13–14, 26, 112n, 130–133

Scientific Advisory Committee for Organ Transplantation, 133

U.S. Food and Drug Administration (FDA), 7–8, 93–94, 101, 106–107, 113–114, 117

establishing licensure of cord blood units, 8, 94

regulation of human cell, tissue, and cellular and tissue-based products, 18, 92–94, 102, 112n, 136

V

Variant Creutzfeldt-Jakob disease (vCJF), 191

Viacord, 80

Volunteers carrying the same allele, A*0201, examples of, 256

W

West Nile virus (WNV), 169, 190

White blood cell (WBC), 38

Wiskott-Aldrich syndrome, clinical use of cord blood in treating, 62

Women. See Pregnant women

World Health Organization (WHO), 251

HLA Nomenclature Committee, 249

World Marrow Donor Association (WMDA), 172, 258

X

Xenogenic transplantation, 68

Y

Y-chromosome-positive cells, 211–213

Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 301
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 302
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 303
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 304
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 305
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 306
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 307
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 308
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 309
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 310
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 311
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 312
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 313
Suggested Citation:"Index." Institute of Medicine. 2005. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: The National Academies Press. doi: 10.17226/11269.
×
Page 314
Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program Get This Book
×
Buy Hardback | $65.00 Buy Ebook | $49.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

With the potential for self-renewal and differentiation, the possibilities for stem cells are enormous. One specific type of stem cell, the hematopoietic progenitor cell (HPC), which is derived from umbilical cord blood (as well as adult bone marrow and mobilized peripheral blood), holds particular promise. To make the most of these HPCs, the Institute of Medicine was asked to consider the optimal structure for a national cord blood program and to address pertinent issues related to maximizing the potential of stem cell technology. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program examines:

  • The role of cord blood in stem cell transplantation
  • The current status of blood banks already in existence
  • The optimal structure for the cord blood program
  • The current use and utility of cord blood for stem cell transplants
  • The best way to advance the use of cord blood units and make them available for research Expert advice from leaders in the fields of economics, public health, medicine, and biostatistics combine to make this very timely and topical book useful to a number of stakeholders.
  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!