C
SURVEY RESULTS

TABLE C-1 Banks That Responded

Bank

State

American Red Cross North Central Blood Services Cord Blood Program

MN

Carolinas Cord Blood Bank

NC

Children’s Hospital of Orange County Cord Blood Bank

CA

Cord Blood Registry

CA

Cryobanks International, Inc.

FL

ITxM Cord Blood Services

IL

JP McCarthy Cord Stem Cell Bank

MI

Lifebank USA

NJ

LifeCord

FL

LifeStor

VA

Michigan Community Blood Centers Cord Blood Bank

MI

National Cord Blood Program of the New York Blood Center

NY

New Jersey Cord Blood Bank

NJ

Puget Sound Blood Center and Hawaii Cord Blood Bank

WA

Sibling Donor Cord Blood Program Children’s Hospital Oakland Research Institute

CA

South Texas Blood & Tissue Center

TX

St. 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



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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program C SURVEY RESULTS TABLE C-1 Banks That Responded Bank State American Red Cross North Central Blood Services Cord Blood Program MN Carolinas Cord Blood Bank NC Children’s Hospital of Orange County Cord Blood Bank CA Cord Blood Registry CA Cryobanks International, Inc. FL ITxM Cord Blood Services IL JP McCarthy Cord Stem Cell Bank MI Lifebank USA NJ LifeCord FL LifeStor VA Michigan Community Blood Centers Cord Blood Bank MI National Cord Blood Program of the New York Blood Center NY New Jersey Cord Blood Bank NJ Puget Sound Blood Center and Hawaii Cord Blood Bank WA Sibling Donor Cord Blood Program Children’s Hospital Oakland Research Institute CA South Texas Blood & Tissue Center TX St. 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

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program TABLE C-2 Type of Bank PUBLIC BANKS American Red Cross North Central Blood Services Cord Blood Program JP McCarthy Cord Stem Cell Bank Michigan Community Blood Centers Cord Blood Bank National Cord Blood Program of the New York Blood Center New Jersey Cord Blood Bank South Texas Blood & Tissue Center St. Louis Cord Blood Bank University of Colorado Cord Blood Bank PRIVATE BANKS Cord Blood Registry LifeStor Sibling Donor Cord Blood Program Children’s Hospital Oakland Research Institute Viacord BANKS THAT OFFER BOTH Carolinas Cord Blood Bank Children’s Hospital of Orange County Cord Blood Bank Cryobanks International, Inc. 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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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program TABLE C-3 Self-Reported Accreditationa Bank FACT AABB Otherb American Red Cross North Central Blood Services Cord Blood Program   X   Carolinas Cord Blood Bank X   FACT pending, NMDP Children’s Hospital of Orange County Cord Blood Bank X   JCAHO, California Tissue Bank License, Seeking FACT Accreditation Cord Blood Registry   X   Cryobanks International, Inc.   X   ITxM Cord Blood Services     Will apply for FACT this fall JP McCarthy Cord Stem Cell Bank     NMDP Lifebank USA   X ISO LifeCord X X NMDP Michigan Community Blood Centers Cord Blood Bank   X FDA Registration National Cord Blood Program of the New York Blood Center X   New York State Board of Health New Jersey Cord Blood Bank       Puget Sound Blood Center and Hawaii Cord Blood Bank   X   Sibling Donor Cord Blood Program Children’s Hospital Oakland Research Institute X   California State Biologies, California State Tissue Bank (both current) St. Louis Cord Blood Bank   X CAP StemCyte, Inc. and Cord Blood Family Trust   X ASHI, NMDP, CAP, California Biologics License, CLIA, FACT pending The Elie Katz Umbilical Cord Blood Program   X   University of Colorado Cord Blood Bank X     Viacord   X CLIA, CAP proficiency, NY State, NJ State, KY State, PA State, registered with FDA and IL State, and MD tissue bank permit aThe accreditation status of the banks was not independently verified. bThe definitions of the acronyms are provided at the end of this appendix.

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program TABLE C-4 Numbers of Collected, Stored, and Transplanted Units Bank Consenting to Collect Collected Banked Available Searchable Used for Transplant Note American Red Cross North Central Blood Services Cord Blood Program 23,130 18,680 6,069 5,962 5,962 242 8 not transplanted Carolinas Cord Blood Bank 17,519 17,000 8,300 7,800 7,800 320   Children’s Hospital of Orange County Cord Blood Bank 3390 2,900 1,550 1,375 1,350 7   Cryobanks International, Inc. 17,741 15,429 9,439 7,485 7,485 5 4 public, 1 private ITxM Cord Blood Services 9,867 5,280 5,000 2,620 2,513 20 Consenting refers to collection kits requested JP McCarthy Cord Stem Cell Bank 3323 2,486 600 517 445 4   Lifebank USA 17,807 17,228 16,264 3,300 3,300 1   LifeCord 1 7,429 1,975 1,474 1,474 10   LifeStor 102 96   Michigan Community Blood Centers Cord Blood Bank 6,665 5,531 1,497 1,386 1,375 6   National Cord Blood Program of the New York Blood Center 27,328 29,525 25,989 25,989 25,989 1,765 Includes first and second transplantations and multiple-unit grafts New Jersey Cord Blood Bank   2,621 1,984 1,796 1,796 7  

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program Bank Name Consenting to Collect Collected Banked Available Searchable Used for Transplant Note Puget Sound Blood Center and Hawaii Cord Blood Bank 3,877 2,358 1,097 727 727 5   Sibling Program Children’s Hospital Oakland Research Institute 1,556 1,438 1,378 1,064 0 43   St. Louis Cord Blood Bank 40,000 40,000 10,000 10,000 10,000 656 10,000 means >10,000. Searches include NMDP, CRIR, and direct searches. Transplants are through June 30, 2004 StemCyte, Inc. and Cord Blood Family Trust 16,777 13,566 8,558 8,331 8,331 78   The Elie Katz Umbilical Cord Blood Program   3,635 2,473 2,473 1,511 25   University of Colorado Cord Blood Bank 10,000 9,943 7,017 6,669 6,435 234 Total consenting not known with precision Viacord 60,000 60,000     0 14 60,000 means >60,000. Every consent resulted in a collection. Total 259,083 255,145 109,190 62,979 60,504 3,384  

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program FIGURE C-1 Total units collected, by bank.

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program TABLE C-5 Banks That Are Currently Collecting Units Bank American Red Cross North Central Blood Services Cord Blood Program Carolinas Cord Blood Bank Children’s Hospital of Orange County Cord Blood Bank Cord Blood Registry Cryobanks International, Inc. ITxM Cord Blood Services JP McCarthy Cord Stem Cell Bank Lifebank USA/Anthrogenesis Corp. 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. and Cord Blood Family Trust The Elie Katz Umbilical Cord Blood Program Viacord FIGURE C-2 Available units—across all banks.

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program TABLE C-6 Racial Makeup of Inventory   Percent Available Asian African American Hispanic Native American Middle Eastern Caucasian Unknown Multiracial Other Averages by total number of units 5.79 11.60 16.81 1.02 0.11 56.08 4.89 3.01 0.69 BY BANK American Red Cross North Central Blood Services Cord Blood Program 2.47 6.59 12.03 0.37   64.64 13.90     Carolinas Cord Blood Bank 2.21 19.52 9.26 0.14 0.00 59.15 0.02 9.21 0.50 Children’s Hospital of Orange Country Cord Blood Bank 17.70 0.67 35.40 2.67   43.55 0.00 0.00 0.00 Cryobanks International, Inc. 1.92 8.06 11.16 1.12 0.57 67.24 0.28 9.65   ITxM Cord Blood Services 3.72 2.16 5.58 1.38 0.00 86.46   0.43 0.26 JP McCarthy Cord Stem Cell Bank 0.45 80.67 2.25 0.22   6.52   9.66 0.22 LifeCord 0.83 3.32 2.76 0.00 0.41 82.72   9.95   Michigan Community Blood Centers Cord Blood Bank 1.17 2.20 3.03 1.38   64.19 28.03     National Cord Blood Program of the New York Blood Center 7.70 21.00 21.10     45.60 4.60     New Jersey Cord Blood Bank 2.17 7.24 0.50 0.89 0.39 61.41     27.39 Puget Sound Blood Center and Hawaii Cord Blood Bank 33.01 1.79 4.54 4.26   56.40       St. Louis Cord Blood Bank 0.66 1.59 0.28 4.69   84.35 0.94 7.50   StemCyte, Inc. and Cord Blood Family Trust 14.99 4.00 51.01 0.39   27.00 2.62     The Elie Katz Umbilical Cord Blood Program 2.02 2.95 10.96 0.08 1.05 42.74 40.19 0.00 0.00 Averages by bank 6.50 11.55 12.13 1.35 0.41 56.57 10.06 5.80 4.73

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program TABLE C-7 Criteria to Determine Which Units Are Suitable for Banking Bank Threshold of Nucleated Cell Dose Volume Bacterial Contamination (Negative) American Red Cross North Central Blood Services Cord Blood Program Preprocessing TNC of 1.2 × 109 50 ml X Carolinas Cord Blood Bank 9 × 108 60 ml X Children’s Hospital of Orange County Cord Blood Bank 9 × 108 40 ml minimum X Cryobanks International, Inc. Precount >8 × 108 60 g X ITxM Cord Blood Services   40 ml collection per NMDP IND X JP McCarthy Cord Stem Cell Bank     X Lifebank USA TNC = 5 × 108 35 ml X LifeCord 8 × 108 TNC preprocessing ≥40 ml   Michigan Community Blood Centers Cord Blood Bank 11 × 108, minority threshold = 9.5 × 108 45 ml X National Cord Blood Program of the New York Blood Center 9 × 108   X

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program 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 for Class I HLA, highresolution DRB1 Tests negative for homozygous hemoglobinopathies; positive CFU growth 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 (molecular test, SSP) No evidence of viral infection for HIV/HILV-1/11, hepatitis B or C virus, CMV by culture or DNA PCR testing.

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program Bank Threshold of Nucleated Cell Dose Volume Bacterial Contamination (Negative) New Jersey Cord Blood Bank minimum of 1.5 × 108 preprocessing, 1.2 × 108 postprocessing >40 ml of cord blood X Puget Sound Blood Center and Hawaii Cord Blood Bank 9 × 108 40 ml   Sibling Program Children’s ≤ Hospital Oakland Research Institute 3 × 108 ≤20 cc   St. Louis Cord Blood Bank >8.0 × 108 45 ml X StemCyte, Inc. and Cord Blood Family Trust   50 ml public, 10 ml private X The Elie Katz Umbilical Cord Blood Program 4 × 108 TNC for autologous storage and 6 × 108 TNC for allogeneic if less than 50 ml then check TNC X University of Colorado Cord Blood Bank TNC greater than 109* ≥95 ml collected* X Viacord 100 × 106 TNC ≥10 ml  

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program 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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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program TABLE C-17 Funding of Public Banks Bank When NIH Private/Philanthropy State Funding American Red Cross North Central Blood Services Cord Blood Program Currently       Historically   X   Carolinas Cord Blood Bank Currently         Historically X X   Children’s Hospital of Orange County Cord Blood Bank Currently   X   Historically   X   ITxM Cord Blood Services Currently   X     Historically   X   LifeCord Currently         Historically       Michigan Community Blood Centers Cord Blood Bank Currently   X   Historically   X   National Cord Blood Program of the New York Blood Center Currently   X   Historically X X   New Jersey Cord Blood Bank Currently     X   Historically   X X Puget Sound Blood Center and Hawaii Cord Blood Bank Currently   X   Historically   X   Sibling Program Children’s Hospital Oakland Research Institute Currently X X   Historically X X   St. Louis Cord Blood Bank Currently   X     Historically   X   StemCyte, Inc and Cord Blood Family Trust Currently   X   Historically   X   The Elie Katz Umbilical Cord Blood Program Currently       Historically   University of Colorado Cord Blood Bank Currently       Historically      

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program 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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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program TABLE C-18 Neonatal Health Status Follow-Up Bank If There Is Follow-Up in Neonatal Health Status, When Is It Done? American Red Cross North Central Blood Services Cord Blood Bank Delivery data are assessed 24 hours or more after delivery. In addition, donors are reminded in a follow-up letter/survey mailed 60 days after delivery and in a birthday card sent at 1 year, to ask the family to report on any changes in infant’s health. Carolinas Cord Blood Bank Yes, 24-hour review of pediatric exam/neonatal history 6 months or more, computer system; mom’s age > 35 years and no amniocentesis follow-up unit at time of request Children’s Hospital of Orange County Cord Blood Bank None Cryobanks International, Inc. No follow-up of neonatal health status is done at present ITxM Cord Blood Services Yes, before release for transplantation; not always able to locate the mother JP McCarthy Cord Stem Cell Bank No follow-up after the baby has been discharged from the hospital Lifebank USA No LifeCord No. However, the mother is asked to call if a health problem arises; the bank receives notification of leukemia in an infant whose cord blood was donated. Michigan Community Blood Centers Cord Blood Bank (1) No formal follow-up. (2) Donor moms are given a card to keep in baby’s book asking for notification if child becomes seriously ill. National Cord Blood Program of the New York Blood Center No New Jersey Cord Blood Bank Follow-up from the donor is requested at 6 months and 1 year Puget Sound Blood Center and Hawaii Cord Blood Bank Yes, prior to transplant (when a cord blood unit has been selected for use) Sibling Program Children’s Hospital Oakland Research Institute Hemoglobinopathy screening is performed on the cord blood unit. Clinical status of donor is reviewed before release of the unit for transplantation

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program How Is Follow-Up Performed? Postcard Phone Call to Mother Other     X X   Review of medical record from pediatrician office   X   X       X       X

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program Bank If There Is Follow-Up in Neonatal Health Status, When Is It done? St. Louis Cord Blood Bank Yes, 2 weeks postdelivery and when confirmatory typing is requested on a cord blood unit StemCyte, Inc. and Cord Blood Family Trust The mother is asked to notify the bank of any change in the health status of the child. A letter with a SASE requesting a response regarding the health of the child is sent between 6 months and 1 year postdelivery. The Elie Katz Umbilical Cord Blood Program No for public units; yes for private units University of Colorado Cord Blood Bank No Viacord Not proactive, at customer request

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program How Is Follow-Up Performed? Postcard Phone Call to Mother Other   X       X

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program TABLE C-19 How the Units Are Stored   Stored as Bank Whole Blood Volume Reduction Only RRC Depleted/Mononuclear Cell Product American Red Cross North Central Blood Services Cord Blood Bank     X Carolinas Cord Blood Bank     X Children’s Hospital of Orange County Cord Blood Bank     X Cryobanks International, Inc.     X ITxM Cord Blood Services X   X JP McCarthy Cord Stem Cell Bank     X Lifebank USA     X LifeCord X (<50 processed this way)   X Michigan Community Blood Centers Cord Blood Bank     X National Cord Blood Program of the New York Blood Center     X New Jersey Cord Blood Bank     X Puget Sound Blood Center and Hawaii Cord Blood Bank     X Sibling Program Children’s Hospital Oakland Research Institute   X   St. Louis Cord Blood Bank       StemCyte, Inc. and Cord Blood Family Trust       The Elie Katz Umbilical Cord Blood Program       University of Colorado Cord Blood Bank     X Viacell     X

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program Other Anticoagulant Used Cryoprotectant Used   CPD DMSO/dextran   X X   X X   CPD solution Stemsol-DMSO, 99% purity,   USP USP grade X CPD DMSO-dextran     X   X X   CPD-Adenine DMSO 10%, HES 1%, dextran40 1%   X X   ACD-A DMSO   CPD DMSO-dextran 40, (unit nos. 668 to present) DSMO-pentastarch-plasma (unit nos 1 to 667) Buffy coat (RBC and plasma reduced) CPD DMSO Plasma depleted, non-redcell-depleted product CPD solution DMSO-Gentran Red cell depleted with volume reduction CPD 10% DMSO   CPD DMSO   CPD DMSO

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program 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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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program 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