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Results of the Cord Blood Transplantation Study (COBLT) Unrelated Donor Banking Program from Donor Screening to Characterization of Banked Units Joanne.

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Presentation on theme: "Results of the Cord Blood Transplantation Study (COBLT) Unrelated Donor Banking Program from Donor Screening to Characterization of Banked Units Joanne."— Presentation transcript:

1 Results of the Cord Blood Transplantation Study (COBLT) Unrelated Donor Banking Program from Donor Screening to Characterization of Banked Units Joanne Kurtzberg, MD 1, Elizabeth L Wagner, MPH 2, John K Fraser, PhD 3, Mitch S Cairo, MD 4, LeeAnn Jensen PhD 5, Geoff Cohen MS 2, Shelly L Carter, ScD 2, Nancy A Kernan, MD 6 and *** 7. 1 Duke University Medical Center, Durham, North Carolina, ; 2 The EMMES Corporation, Rockville, Maryland, ; 3 University of California, Los Angeles, California, ; 4 Georgetown University Medical Center, Washington DC, ; 5 National Heart, Lung and Blood Institute, Bethesda, Maryland, ; 6 Memorial Sloan-Kettering Cancer Center, New York, New York, and 7 ***sponsored by the National Heart, Lung and Blood Institute, Bethesda, Maryland, 20817

2 Background COBLT: The Cord Blood Transplantation Study – sponsored by the NHLBI COBLT: The Cord Blood Transplantation Study – sponsored by the NHLBI –Banking study –Transplant Study Initiated in 1996 and funded: Initiated in 1996 and funded: –1 Coordinating Center (EMMES) –3 Cord Blood Banks Choc/GTMitch Cairo Choc/GTMitch Cairo DukeJoanne Kurtzberg DukeJoanne Kurtzberg UCLAJohn Fraser UCLAJohn Fraser –7 Transplant Centers 21 additional centers added over tenure of the study 21 additional centers added over tenure of the study

3 Banking Study: Plan of Attack Steering Committee: Steering Committee: –Chair, Nancy Kernan, MD –Bank Directors –Coordinating & StatisticalCenter - EMMES –Representatives from NHLBI –Transplanters, OB, Ethicist, Lab Techs Created and validated SOPs for program Created and validated SOPs for program –Monthly meeting x 18 months

4 Standard Operating Procedures SOPs SOPs –Donor screening and recruitment –Donor education and consent –Maternal donor medical history and testing –Collection and transportation –Processing and cryopreservation –Maternal Sample and Cord Blood Testing –Quarantine and release –Long term storage –Search Registry

5 SOPs - Continued Standardization and validation of laboratory procedures Standardization and validation of laboratory procedures –HLA by molecular techniques –Cell counts, viability, CFUs, CD34 and subsets, CD3,4,8, CD19, CD16/56 Creation of internet based banking data system and search registry Creation of internet based banking data system and search registry Interlaboratory/bank QA/QC program with sample exchanges for testing, HLA typing, banking and thawing Interlaboratory/bank QA/QC program with sample exchanges for testing, HLA typing, banking and thawing

6 Study Eligibility Collections ex utero Collections ex utero UCBs >40 ml or 6x10e8 TNC UCBs >40 ml or 6x10e8 TNC Initiation of processing within 48h of collection Initiation of processing within 48h of collection Recovery of >60% of TNC post processing Recovery of >60% of TNC post processing –+CFU growth Negative maternal ID testing and maternal and family risk history Negative maternal ID testing and maternal and family risk history Negative homozygous hemoglobinopathy Negative homozygous hemoglobinopathy All banked units passed a study algorithm defined by the steering committee All banked units passed a study algorithm defined by the steering committee

7 Timeline Recruitment initiated in October, 1997 Recruitment initiated in October, 1997 Collections initiated in December, 1997 Collections initiated in December, 1997 SOPs published 1998 SOPs published 1998 –Fraser et al, J Hematotherapy 7: – – Collections completed June, Collections completed June, 2001.

8 Figure 1 - Numbers of Women Screened, Approached, Consenting and with Collections Made Data from Monthly Recruitment Forms April 1998 to March 2001

9 Figure 2 - Numbers of Collections Made, Cryopreserved and Banked (December 1997 to August 2001) Reasons for discard NumberPercent Insufficient volume/cell count Positive maternal ID test Maternal history exclusion Processing issues Collection issues No maternal sample Subsequent medical information Failed post-processing sterility test Insufficient cell recovery Withdrew consent 90 1 Administrative issues 57 1 Shipping/storage issues 91 1 Missing 5 0 Total Cryopreserved Total collections Moved to long-term storage 9112 Already shipped 303 Available in bank8133 Still in quarantine %64% Discarded % Discarded %

10 Table 1 - Influence of Type of Delivery on Cell Counts and Volume Note :All differences highly significant (P< ). VaginalC-sectionALL N=6736N=2315N=9051 Pre-processing Volume (ml) Total viable nucleated cells (x10 8 ) Post-processing Total CD34+ cells (x10 6 ) Average CD34+cells per uL Total CD3+ cells (x10 8 ) Average CD3+ cells per uL

11 Table 2 - Weight, Volume and Cell Counts of Stored CBUs by Ethnic Group CaucasianAfricanAmericanAsianHispanicMixed/OtherAll N=370140%N=131614%N=111412%N=191021%N=107112%N=9112 Pre-processing Volume (ml) Total viable nucleated cells x Post-processing Total viable nucleated cell x Total CD34+ cells x Average CD34+cells per uL Total CD3+ cells x Average CD3+ cells per uL

12 Table 3 - Percent of Collections Stored by Mother's Ethnicity Race All Collected DiscardedStored Percent Stored Caucasian 6784 (39%) % African American 2842(17%) % Asian1914(11%) % Hispanic3494(20%) % Mixed2173(13%) % TOTAL %

13 Table 4 - Correlations of Cell Counts, CBU Volume, Infant Birth Weight and Gestational Age *** P<0.001 Volume Birth Weight Gestational Age TNCCCD34 Birth Weight 0.28*** Gestational Age *** TNCC0.66***0.25***0.12*** CD340.31***0.12***-0.04***0.48*** CD30.48***0.13***0.03***0.59***0.31***

14 Figure 2a - Total Nucleated Cells by Birth Weight < > TNC (x 10 8 ) Birth weight (kg)

15 < > CD34 (x 10 6 ) Birth weight (kg) Figure 2b - Total CD34 Cells by Birth Weight Bars show mean and 95% confidence limits (mean +/ standard errors).

16 < > TNC (x 10 8 ) Gestational Age (weeks) Figure 2c - Total Nucleated Cells by Gestational Age

17 Figure 2d - Total CD34 Cells by Gestational Age < > CD34 (x 10 6 ) Gestational Age (weeks)

18 Figure 3 - Adjusted Mean Total Post-Processing CD34 Counts by Race Caucasian African American Asian HispanicOther Adjusted mean CD34+ (x 10 6 ) Total post processing count

19 Conclusions The COBLT Banking Study has demonstrated the resources required to establish and maintain a network of cord blood banks with common SOPs and Quality Systems. The COBLT Banking Study has demonstrated the resources required to establish and maintain a network of cord blood banks with common SOPs and Quality Systems. A MCC (EMMES) created and maintains a web based data management system for data collection and analysis. A MCC (EMMES) created and maintains a web based data management system for data collection and analysis.

20 Conclusions >35,000 women were recruited and screened over 3 years. >35,000 women were recruited and screened over 3 years. 15% refused to participate in the study. 15% refused to participate in the study. Approximately 53% of CBUs collected from these donors were successfully banked creating an ethnically diverse inventory of >8,000 total units. Approximately 53% of CBUs collected from these donors were successfully banked creating an ethnically diverse inventory of >8,000 total units. The main reasons for exclusion were insufficient cell volume/counts or positive ID testing on the maternal sample. The main reasons for exclusion were insufficient cell volume/counts or positive ID testing on the maternal sample.

21 Conclusions Strong correlations were observed between UCB collection volume and nucleated cell and CD34 content. Strong correlations were observed between UCB collection volume and nucleated cell and CD34 content. Units collected from African American donors had lower cell counts and CD34 counts per ml of UCB collected. Units collected from African American donors had lower cell counts and CD34 counts per ml of UCB collected. Factors correlating with higher UCB TNC content included higher birth weight, delivery by c-section and increasing gestational age at delivery (not beyond 40 weeks). Factors correlating with higher UCB TNC content included higher birth weight, delivery by c-section and increasing gestational age at delivery (not beyond 40 weeks).

22 Conclusions These observations can be used to create an algorithm for identification of desirable units at a collection site to maximize resources committed to units that are processed, tested and banked. These observations can be used to create an algorithm for identification of desirable units at a collection site to maximize resources committed to units that are processed, tested and banked.

23 Acknowledgements NHLBI: LeeAnn Jensen, Paul McCurdy NHLBI: LeeAnn Jensen, Paul McCurdy Study Chair: Nancy Kernan Study Chair: Nancy Kernan The MCC – The EMMES Corporation The MCC – The EMMES Corporation –Shelly Carter, Liz Wagner, Geoff Cohen Bank Directors Bank Directors –Mitch Cairo, John Fraser, Joanne Kurtzberg HLA HLA –UCSF, UCLA, NMRI


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