Cord Blood Establishing a National Hematopoietic Stem Cell Bank Program (2005) / Chapter Skim
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Appendix C: Survey Results
Appendix C: Survey Results
Pages 160-207
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From page 160... ...
Louis Cord Blood Bank MO StemCyte International Cord Blood Center and Cord Blood Family Trust CA The Elie Katz Umbilical Cord Blood Program NJ University of Colorado Cord Blood Bank CO Viacord MA 160
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From page 161... ...
ITxM Cord Blood Services Lifebank USA LifeCord Puget Sound Blood Center and Hawaii Cord Blood Bank StemCyte Inc. and Cord Blood Family Trust The Elie Katz Umbilical Cord Blood Program at Community Blood Services Totals: 8 Public, 4 Private, 9 Mixed
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From page 162... ...
St. Louis Cord Blood Bank X CAP StemCyte, Inc.
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From page 163... ...
163 to second and continues requested and grafts private refers 1 kits first transplanted not public, Note 8 4 Consenting collection Includes transplantations multiple-unit for 7 5 4 1 6 7 20 10 242 320 Used Transplant 1,765 445 Searchable 5,962 7,800 1,350 7,485 2,513 3,300 1,474 1,375 1,796 25,989 517 Available 5,962 7,800 1,375 7,485 2,620 3,300 1,474 1,386 1,796 Units 25,989 600 6,069 8,300 1,550 9,439 5,000 1,975 1,497 1,984 Banked 16,264 25,989 96 Transplanted 2,900 5,280 2,486 7,429 5,531 2,621 Collected 18,680 17,000 15,429 17,228 29,525 and 1 102 Collect 3390 9,867 3323 6,665 Stored, Consenting to 23,130 17,519 17,741 17,807 27,328 the Collected, County of Bank of Central Centers Program Inc. Cell Bank Bank Orange Blood North Blood Program of Services Stem Center Blood Numbers Cross Cord Blood Blood Cord Bank Blood Bank Cord C-4 Red Cord Hospital International, USA Community Blood Cord Services Blood Cord Blood York Jersey McCarthy TABLE Bank American Blood Carolinas Children's Cord Cryobanks ITxM JP Lifebank LifeCord LifeStor Michigan Cord National New New
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From page 164... ...
164 in NMDP, searches. not through >10,000.
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From page 165... ...
165 Blood Cord LifeStor 96 Institute Research Oakland Hospital Children's Program Blood Cord Donor Sibling 1,438 Bank Blood Cord Hawaii and Center Blood Sound Puget 2,358 Center/ issue T Northwest Bank Cell Stem Cord McCarthy JP 2,486 Bank Blood Cord Jersey New 2,621 Bank Blood Cord County Orange of Hospital s Children' 2,900 Services Blood Community at Program Blood Cord 3,635 Umbilical Katz Elie The Services Blood Cord ITxM 5,280 Bank Blood Cord Centers Blood Community Michigan 5,531 LifeCord 7,429 Bank Blood Cord Colorado of University 9,943 rust T Family Blood Cord and Bank Blood Cord International StemCyte 13,566 Inc International, Cryobanks 15,429 Bank Blood Cord Carolinas 17,000 USA Lifebank bank. 17,228 by Blood Cord Cross Red American 18,680 Center Blood ork Y Program-New Blood Cord National collected, 29,525 Bank Blood Cord Louis St.
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From page 166... ...
LifeCord Michigan Community Blood Centers Cord Blood Bank National Cord Blood Program of the New York Blood Center New Jersey Cord Blood Bank Puget Sound Blood Center and Hawaii Cord Blood Bank Sibling Program Children's Hospital Oakland Research Institute St. Louis Cord Blood Bank StemCyte, Inc.
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From page 167... ...
167 0.69 0.50 0.00 0.26 0.22 0.00 4.73 Other 27.39 Multiracial 3.01 9.21 0.00 9.65 0.43 9.66 9.95 7.50 0.00 5.80 4.89 0.02 0.00 0.28 4.60 0.94 2.62 Unknown 13.90 28.03 40.19 10.06 Caucasian 6.52 56.08 64.64 59.15 43.55 67.24 86.46 82.72 64.19 45.60 61.41 56.40 84.35 27.00 42.74 56.57 0.11 0.00 0.57 0.00 0.41 0.39 1.05 0.41 Middle Eastern Native American 1.02 0.37 0.14 2.67 1.12 1.38 0.22 0.00 1.38 0.89 4.26 4.69 0.39 0.08 1.35 9.26 5.58 2.25 2.76 3.03 0.50 4.54 0.28 Hispanic 16.81 12.03 35.40 11.16 21.10 51.01 10.96 12.13 6.59 0.67 8.06 2.16 3.32 2.20 7.24 1.79 1.59 4.00 2.95 Available African American 11.60 19.52 80.67 21.00 11.55 5.79 2.47 2.21 1.92 3.72 0.45 0.83 1.17 7.70 2.17 0.66 2.02 6.50 Percent Asian 17.70 33.01 14.99 Inventory Cord New of Blood the Country of Hawaii Family units Bank Blood Central Centers of and Inc. Makeup Cell Bank Blood Cord Program Bank Orange Blood North Program Bank of number Services Stem Center Cord Blood Racial Blood Blood Cross Bank Blood Blood and total Cord Center Bank Umbilical International, Blood Blood Cord bank C-6 by Red Cord Cord Hospital Community Inc.
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From page 168... ...
Precount >8 × 108 60 g X ITxM Cord Blood Services 40 ml X collection per NMDP IND JP McCarthy Cord Stem Cell X Bank Lifebank USA TNC = 5 × 108 35 ml X LifeCord 8 × 108 TNC 40 ml preprocessing Michigan Community Blood 11 × 108, minority 45 ml X Centers Cord Blood Bank threshold = 9.5 × 108 National Cord Blood 9 × 108 X Program of the New York Blood Center
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From page 169... ...
APPENDIX C 169 Level of HLA Resolution Other Donation is excluded if: · unit is reactive for infectious disease markers · unit has less than 70 percent postprocessing and prefreezing viability · there is a family history of diseases, conditions, and/or genetic disorders that may affect the recipient · the mother has symptoms of or has been diagnosed with certain infectious diseases including West Nile virus, parasitic blood diseases, syphilis, hepatitis, and HIV/AIDs · the mother has engaged in behaviors or received medical treatments that increase the risk of contracting these diseases Intermediate resolution Tests negative for homozygous hemoglobinopathies; for Class I HLA, high- positive CFU growth resolution DRB1 Negative infectious disease testing on maternal blood Negative maternal infectious disease markers, processed within 36 hours of collection Maternal and baby health questionnaire eligibility Infectious disease testing, microbiology testing, hemaglobinopathy screen, viability Infectious disease markers, ABO and RH type determination of cord blood unit, newborn screening retention samples, maternal medical health questionnaire, review of maternal and newborn medical records Virology negative (except for CMV) Negative infectious disease test results, lack of family medical history of inherited genetic disorders or diseases, no inappropriate affirmative responses to questions from risk behavior questionnaire Negative infectious disease testing, normal genetic screen "We also apply the same deferral criteria as that of whole blood donors for risk factors" Class I antigen level No evidence of viral infection for HIV/HILV-1/11, (molecular test, SSP)
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From page 170... ...
Louis Cord Blood Bank >8.0 × 108 45 ml X StemCyte, Inc. and Cord 50 ml public, X Blood Family Trust 10 ml private The Elie Katz Umbilical 4 × 108 TNC for if less than X Cord Blood Program autologous storage 50 ml then and 6 × 108 TNC check TNC for allogeneic University of Colorado Cord TNC greater than 95 ml X Blood Bank 109*
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From page 171... ...
APPENDIX C 171 Level of HLA Resolution Other HLA-A HLA-B, and DRB1 Maternal health history, maternal infectious disease intermediate resolution screening, 6-month and 1-year follow-up of child's health Complications and/or congenital abnormalities observed Since units are all related, we bank as many as possible CD34+ and CF4 values, viability Intermediate-resolution Infectious disease markers (only positives banked are HLA-A and HLA-B, high- CMV and Hepatitis B core) , maternal health history resolution DRB1 and family genetic history Negative viral marker results HLA-A, HLA-B Negative infectious disease markers, no risk factors from serological equivalent, maternal donor questionnaire, complete consent HLA-DRB1 high resolution Criteria with "*
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From page 172... ...
transplant center criteria ITxM Cord Blood X Services JP McCarthy Cord X Stem Cell Bank Lifebank USA IRB approved protocol, agreeing to provide post-transplant data LifeCord X Michigan IRB approved transplant protocol Community Blood Centers Cord Blood Bank National Cord Must have a recognized track record Blood Program of in BMT, and accreditation by EBMT, the New York JACIE, etc. Blood Center New Jersey Cord X Written prescription from transplant Blood Bank center Puget Sound Blood X Signed agreement and memorandum Center and Hawaii of understanding Cord Blood Bank St.
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From page 173... ...
APPENDIX C 173 How Bank Is Most Commonly Accessed by Transplant Center Direct NETTransplant Center Exceptions Contact CORD NMDP Other Exceptions allowed on basis X of approval by medical director Medical director has personal X X parents or knowledge of transplant center referring physician N/A X Medical director approval CRIR Private family units do not need to go X X to NMDP centers NMDP will permit compassionate-use X requests for nonmember transplant centers BMDW X X CRIR X X X X CRIR X X CRIR continues
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From page 174... ...
transplant centers, Cord Blood Family this does not apply Trust The Elie Katz IRB, if available, request form Umbilical Cord Blood Program University of Must meet WMD recommendations Colorado Cord and requirements per Goldman et al., Blood Bank 1994, A special report: Bone marrow transplants using volunteer donors- recommendaions and requirements for a standardized practice throughout the world. Blood 84:2833.
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From page 175... ...
APPENDIX C 175 How Bank Is Most Commonly Accessed by Transplant Center Direct NETTransplant Center Exceptions Contact CORD NMDP Other X CRIR Foreign countries X BMDW Compassionate use X CRIR, various foreign national registries
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From page 176... ...
Louis Cord Blood Bank X X X StemCyte, Inc. and Cord Blood Family X X X X Trust The Elie Katz Umbilical Cord Blood X X X Program University of Colorado Cord Blood X X X X Bank Viacord X X or continue storage
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From page 177... ...
Units are bar coded with the ISBT 128 system. Children's Hospital of Yes, bar coded and tracked Orange County Cord Blood Bank ITxM Cord Blood Services Bar coded, tracked in database LifeCord Yes Michigan Community Manual entry into database Blood Centers Cord Blood Bank National Cord Blood Yes Program of the New York Blood Center New Jersey Cord Blood Yes Bank Puget Sound Blood Center Yes; bar coded; also, the location is recorded in the unit and Hawaii Cord Blood chart Bank Sibling Program Children's Units are bar coded and tracked electronically and Hospital Oakland Research manually; a written inventory log is kept Institute St.
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From page 178... ...
Louis Cord Blood Bank X SQL server StemCyte, Inc. and Cord Blood Family X X Trust The Elie Katz Umbilical Cord Blood X X Program University of Colorado Cord Blood X Bank Viacord X X
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From page 179... ...
Louis Cord Blood Bank X StemCyte, Inc. and Cord Blood Family Trust X X X The Elie Katz Umbilical Cord Blood Program X X X University of Colorado Cord Blood Bank X X X Viacord X X X NOTE: No banks answered "Researcher" or "other."
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From page 180... ...
Tear Placenta American Red Cross X X Evaluation of infection is North Central Blood performed by the cord blood Services Cord Blood bank through chart review Program Carolinas Cord X 34 Inflammation of the chorion Blood Bank and the amnion, the membranes that surround the fetus Children's Hospital 36 X of Orange County Cord Blood Bank Cryobanks International, Inc. ITxM Cord Blood X 36 Evidence of infection or odor, X Services pus, temperature >38.5°C JP McCarthy Cord X Stem Cell Bank Lifebank USA X LifeCord 36 Michigan X 36 Per attending physician's Community Blood determination Centers Cord Blood Bank
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From page 181... ...
APPENDIX C 181 Bifida) Strept Spinal B Herpes Structural Chromosome Perineal (e.g., Group Genital or Fetal Fetal Positive Carrier Active Vulvar Condylomata Known Anomalies Known Abnormalities Other X X X Reactive for infectious disease markers Less than 70 percent postprocessing and prefreezing viability There is a family history of diseases, conditions, or genetic disorders that may affect the recipient The mother has symptoms of or has been diagnosed with certain infectious diseases including West Nile virus, parasitic blood diseases, syphilis, hepatitis, and HIV/ AIDS.
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From page 182... ...
Tear Placenta National Cord X Blood Program of the New York Blood Center New Jersey Cord X 34 Blood Bank Puget Sound Blood X Center and Hawaii Cord Blood Bank Sibling Program 32 Children's Hospital Oakland Research Institute St. Louis Cord X 35 Placental infection, Blood Bank malodorous placenta StemCyte, Inc.
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From page 183... ...
APPENDIX C 183 Bifida) Strept Spinal B Herpes Structural Chromosome Perineal (e.g., Group Genital or Fetal Fetal Positive Carrier Active Vulvar Condylomata Known Anomalies Known Abnormalities Other X X X X Stillborn infant Known to be affected by a genetic disease X Maternal or infant temperature >102°F X X Only vaginal deliveries with active genital herpes are deferred; also exclude tumor within or attached to placenta; abruptio placenta X X Temperature >38.5°C, maternal eclampsia and/or maternal HELLP syndrome X X X X X Caesarean section X Customer choice to store or not
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From page 184... ...
Louis Cord Blood Bank X X X X StemCyte, Inc. and Cord Blood Family Trust X X X The Elie Katz Umbilical Cord Blood Program X X X University of Colorado Cord Blood Bank X X X X Viacord X X X
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From page 185... ...
Aminotransferase Alanine X Testing Cord Bank North of Services Stem Continued Blood Cord Cross Services Disease Cord Hospital International, Blood Red Cord C-14 Blood County Bank Bank Cord Bank McCarthy Bank TABLE Infectious American Central Blood Carolinas Children's Orange Blood Cryobanks Inc.
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From page 186... ...
Aminotransferase (continued) Alanine X X X Testing Blood Bank York Center Continued Blood Blood Blood New Blood Disease Blood the Cord Cord C-14 USA Community Cord Cord of Center Jersey Sound Hawaii Bank TABLE Infectious Lifebank LifeCord Michigan Centers National Program Blood New Bank Puget and Bank
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From page 187... ...
187 X X X X X X X X X X X X X X X X X X X X X X X X X X XX X XXXX X X X X X X X XX X X X XX X XX X X X X X XX X XX X XX XX Bank Research Cord Children's Blood and Trust Umbilical Colorado Program Bank Inc. of Oakland Cord Katz Program Family Blood Blood Elie Louis Sibling Hospital Institute St.
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From page 188... ...
188 CORD BLOOD TABLE C-14 Continued Other Exclusions: Other Infectious Disease Testing and Travel Current FDA Travel Bank Other Restrictions American Red Cross North Yes Central Blood Services Cord Blood Bank Carolinas Cord Blood Bank Yes Children's Hospital of Orange HIV 1 and 2 NAT Yes County Cord Blood Bank Cryobanks International, Inc. HBV Ab and CMV, total by PCR Yes ITxM Cord Blood Services Yes JP McCarthy Cord Stem Cell HIV and HCV NAT; HBV NAT Yes Bank Lifebank USA Yes LifeCord HIV NAT Yes
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From page 189... ...
Mother spent a total time from 1980 to 1996 that adds up to 3 months or more in the United Kingdom (UK) from 1980 to 1996 or she received a blood transfusion in the UK in this time frame.
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From page 190... ...
Other genetic tests performed include for CAH, hypothyroidism, galactosemia, maple syrup urine disease, PKU, MCAD, biotinidase deficiency New Jersey Cord Blood Bank Yes Puget Sound Blood Center and HIV NAT antibody screen Yes Hawaii Cord Blood Bank Sibling Program Children's HIV type 1 NAT No Hospital Oakland Research Institute St. Louis Cord Blood Bank CMV total Ab, HIV NAT StemCyte, Inc.
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From page 191... ...
. Collections from 1996 to 2001 utilized the then-current FDA guidelines for donor exclusion based on travel to foreign countries.
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From page 192... ...
ITxM Cord Collected 0 0 3 63 226 Blood Services Shipped 0 0 0 0 0 JP McCarthy Collected Cord Stem Cell Shipped Bank LifeCord Collected 122 Shipped 0 Michigan Collected Community Shipped Blood Centers Cord Blood Bank National Cord Collected 943 1,739 1,615 920 763 Blood Program -- New York Shipped 2 16 100 214 256 Blood Center New Jersey Collected Cord Blood Shipped Bank Puget Sound Collected 0 0 0 0 0 Blood Center Shipped 0 0 0 0 0 and Hawaii Cord Blood Bank
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From page 193... ...
APPENDIX C 193 1998 1999 2000 2001 2002 2003 2004 2,155 175 2,579 5,062 6,511 3,092 522 10 11 9 22 50 81 59 960 4,136 2,147 1,851 2,326 2,325 1,164 0 9 36 68 76 75 52 0 44 370 510 666 528 375 0 0 0 1 1 1 3 Pr: 251 Pr: 156 Pr: 126 Pr: 159 Pr: 220 Pr: 241 Pr: 75 Pu: 671 Pu: 316 Pu: 337 Pu: 1,168 Pu: 3,983 Pu: 5,256 Pu: 3,010 Pr: 0 Pr: 0 Pr: 0 Pr: 0 Pr: 0 Pr: 1 Pr: 0 Pu: 0 Pu: 0 Pu: 0 Pu: 0 Pu: 0 Pu: 491 Pu: 2 289 1,149 1,740 1,145 388 30 188 0 0 0 2 9 8 1 211 922 921 432 2 2 337 345 287 333 288 168 95 0 0 0 2 0 6 2 124 604 1,086 1,301 1,477 880 0 0 1 1 3 1 255 1,395 2,530 3,301 4,322 4,333 2,884 (as of 8/31/04)
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From page 194... ...
Collected 0 0 0 0 0 and Cord Blood Shipped 0 0 0 0 0 Family Trust The Elie Katz Collected 0 0 0 4 162 Umbilical Cord Shipped 0 0 0 0 0 Blood Program University of Collected 4 569 Colorado Cord Shipped Blood Bank Viacord Collected 67 524 383 Shipped 1 2 7,000 50,000 Collected 48,63846,547 Shipped 6,000 40,000 5,000 32,147 29,650 Units 30,000 4,000 Collected Shipped 22,500 3,000 Units 20,000 17,893 2195 13,463 2,000 10,000 8,698 1097 1,739 1,7173,526 1,000 503 943 214 421 301 100 268 227 252 2 16 0 0 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 (partial year) FIGURE C-3 Units collected and shipped, by year.
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From page 195... ...
APPENDIX C 195 1998 1999 2000 2001 2002 2003 2004 33 160 251 252 307 312 123 2 2 7 5 11 17 2 5,969 5,334 4,237 4,117 5,082 5,377 3,280 1,447 1,188 1,059 1,023 1,286 1,546 843 38 74 96 151 129 110 49 Pu: 4,198 Pu: 7,748 Pu: 1,519 Pu: 101 0 0 0 Pr: 33 Pr: 147 0 0 0 Pu: 2 Pu: 9 Pu: 30 Pu: 37 632 1,066 916 134 157 220 344 0 6 3 5 3 6 4 1,161 1,779 3,935 2,495 3 24 42 44 43 45 33 750 1,560 2,027 5,248 12,826 19,426 18,259 (as of 10/04)
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From page 196... ...
Louis Cord Blood Bank StemCyte, Inc. and Cord $1,450 $95/year No cost Blood Family Trust The Elie Katz Umbilical $1,350 ($1,500 if paid $100/year $0 Cord Blood Program in installment, $900 at specified hospitals)
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From page 197... ...
APPENDIX C 197 Public Reimbursement $18,000 Pending $18,500 $15,500 $15,000 per NMDP $15,500 $25,000 $22,490 -- includes patient CT-negative unit CT-positive Unit DNA for transplant center CT, unit shipment in the United States NMDP provides $15,500 for a unit when it is transplanted. $15,000 $15,000 before 2004, $21,500 after 1/1/04 $0 $17,000
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From page 198... ...
198 CORD BLOOD TABLE C-17 Funding of Public Banks Private/ State Bank When NIH Philanthropy Funding American Red Cross North Central Blood Currently Services Cord Blood Program Historically X Carolinas Cord Blood Bank Currently Historically X X Children's Hospital of Orange County Currently X Cord Blood Bank Historically X ITxM Cord Blood Services Currently X Historically X LifeCord Currently Historically Michigan Community Blood Centers Cord Currently X Blood Bank Historically X National Cord Blood Program of the New Currently X York Blood Center Historically X X New Jersey Cord Blood Bank Currently X Historically X X Puget Sound Blood Center and Hawaii Currently X Cord Blood Bank Historically X Sibling Program Children's Hospital Currently X X Oakland Research Institute Historically X X St. Louis Cord Blood Bank Currently X Historically X StemCyte, Inc and Cord Blood Family Currently X Trust Historically X The Elie Katz Umbilical Cord Blood Currently Program Historically University of Colorado Cord Blood Bank Currently Historically
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From page 199... ...
APPENDIX C 199 Public Bank Revenue Other X X Support From ARC X ARC By participating entities, UF, Shands, LifeSouth By participating entities, UF, Shands, LifeSouth X X X NYBC X NYBC X X X X X Fund raising X Fund raising Private bank revenue Private bank revenue Self-supporting from reimbursement fees University of Colorado Hospital
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From page 200... ...
National Cord Blood No Program of the New York Blood Center New Jersey Cord Blood Follow-up from the donor is requested at 6 months and Bank 1 year Puget Sound Blood Center Yes, prior to transplant (when a cord blood unit has and Hawaii Cord Blood been selected for use) Bank Sibling Program Children's Hemoglobinopathy screening is performed on the cord Hospital Oakland Research blood unit.
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From page 201... ...
APPENDIX C 201 How Is Follow-Up Performed? Postcard Phone Call to Mother Other X X Review of medical record from pediatrician office X X X X continues
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From page 202... ...
The Elie Katz Umbilical No for public units; yes for private units Cord Blood Program University of Colorado No Cord Blood Bank Viacord Not proactive, at customer request
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From page 203... ...
APPENDIX C 203 How Is Follow-Up Performed? Postcard Phone Call to Mother Other X X
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From page 204... ...
Michigan Community Blood Centers Cord X Blood Bank National Cord Blood Program of the X New York Blood Center New Jersey Cord Blood Bank X Puget Sound Blood Center and Hawaii Cord X Blood Bank Sibling Program Children's Hospital Oakland X Research Institute St. Louis Cord Blood Bank StemCyte, Inc.
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From page 205... ...
Plasma depleted, non-red- CPD solution DMSO-Gentran cell-depleted product Red cell depleted with CPD 10% DMSO volume reduction CPD DMSO CPD DMSO
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From page 206... ...
206 CORD BLOOD ACRONYMS AND ABBREVIATIONS AABB American Association of Blood Banks ACD-A Anticoagulant Citrate Dextrose Solution, formula A ARC American Red Cross ASHI American Society for Histocompatibility and Immunogenetics BMDW Bone Marrow Donors Worldwide BMT bone marrow transplant CAH congenital adrenal hyperplasia CAP College of American Pathologists CBB cord blood bank CLIA Clinical Laboratory Improvement Amendments CMV cytomegalovirus CPD citrate-phosphate-dextrose CRIR Caitlin Raymond International Registry DMSO dimethyl sulfoxide EBMT European Group for Blood and Marrow Transplantation FACT Foundation for the Accreditation of Cellular Therapy FDA Food and Drug Administration g gram(s) HbcAb hepatitis B core antibody HBV hepatitis B virus HCV hepatitis C virus HELLP haemolysis, elevated liver enzymes, low platelets HES hetastarch HIV human immunodeficiency virus HLA human leukocyte antigen IgG immunoglobulin G IND investigational new drug IRB institutional review board ISBT International Society of Blood Transfusion ISCT International Society for Cellular Therapy ISO International Organization for Standardization JACIE Joint Accreditation Committee ISCT EBMT
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From page 207... ...
APPENDIX C 207 JCAHO Joint Commission for Accreditation of Healthcare Organizations MCAD medium-chain acyl-CoA dehydrogenase ml milliliter(s) NAT nucleic acid test NIH National Institutes of Health NMDP National Marrow Donor Program NYBC New York Blood Center PCR polymerase chain reaction PKU phenylketonuria RBC red blood cell SARS sudden acute respiratory syndrome SASE self-addressed stamped envelope SQL structured query language SSP split spectrum processing TNC total nucleated cell count UCLA University of California, Los Angeles UF University of Florida USP United States Pharmacopeia vCJF variant Creutzfeldt-Jakob disease WMDA World Marrow Donor Association WNV West Nile virus
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