i. OVERVIEW

1. Results of the cord blood transplantation (COBLT) study unrelated donor banking program. Kurtzberg J, Cairo MS, Fraser JK, Baxter-Lowe L, Cohen G, Carter SL, Kernan NA. Transfusion. 2005;45:842-55.

To meet the ongoing needs of patients, particularly ethnic minorities, the Cord Blood Transplantation (COBLT) Study was conceived by the NHLBI. The COBLT Study is a Phase II, multicenter study designed to determine the utility of UCB for transplantation of patients with malignant and nonmalignant diseases. The goals of the program initiated in 1996 were to develop standard operating procedures (SOPs) for cord blood (CB) donor recruitment and banking and to build an ethnically diverse unrelated CB bank to support a transplantation protocol.

The program included collection centers, three banks, a steering committee, and a medical coordinating center (MCC) that developed and validated SOPs and a Web-based data collection system. External oversight was performed by the National Heart, Lung, and Blood Institute and the MCC.

A total of 34,799 potential donors were screened and 20,710 consented. A total of 17,207 ethnically diverse units were collected between 1998 and 2001. A total of 11,077 (64%) units were cryopreserved and quarantined. Of these, 79 percent met eligibility criteria and were HLA-typed and entered into the search registry. Higher CB volumes and cell counts were obtained from cesarean sections compared to vaginal deliveries. Units from African-American persons contained lower cell counts per volume compared to other ethnicities. Birth weight correlated with volume and cell content. External oversight was accomplished through custom reports generated by the data collection system and periodic site visits. During maintenance, a breach in the SOPs was detected during a site visit at one of the banks. These units were designated for future use in nonclinical research.

In conclusion, the COBLT Study demonstrated that SOPs and data collection can be implemented in multiple banks coordinated by one MCC. Relationships between donor demographics and CB content may be useful in the development of other CB banking programs.

2. Characterization of banked umbilical cord blood hematopoietic progenitor cells and lymphocyte subsets and correlation with ethnicity, birth weight, sex, and type of delivery: a Cord Blood Transplantation (COBLT) Study report. Cairo MS, Wagner EL, Fraser J, Cohen G, van de Ven C, Carter SL, Kernan NA, Kurtzberg J. Transfusion. 2005;45:856-66.

The goals of the Cord Blood Transplantation (COBLT) Study banking program were to develop standard operating procedures for cord blood (CB) donor recruitment and banking and to build an ethnically diverse unrelated CB bank to support a transplantation protocol.

This report describes the hematopoietic progenitor cell (HPC) and lymphocyte subset (LS) content of approximately 8000 CB units, and these results were correlated with donor ethnicity, birth weight, gestational age, sex, and type of delivery.

There was a significant correlation of CD34+ cell count with colony-forming unit (CFU)-granulocyte-macrophage (r=0.68, p<0.001), CFU-granulocyte-erythroid-macrophage-megakaryocyte (r=0.52, p<0.001), burst-forming unit-erythroid (BFU-E; r=0.61, p<0.001), and total CFUs (r=0.67, p<0.001). Nucleated red blood cell count was significantly correlated with total CD34+ (r=0.56, p<0.001), total CFU (r=0.50, p<0.001), BFU-E (r=0.48, p<0.001), and counts of CD34+ subsets (p<0.001). Caucasian ethnicity was significantly correlated with higher CD3+/CD4+, CD19+, and CD16+/CD56+ LSs.

Furthermore, CD34+/CD38- and CD34+/CD61+ CB units (HPC-C) were significantly lower in African American and Asian persons compared to Caucasian and Hispanic persons. Male sex was associated with significantly fewer CD3+/CD4+, CD19+, and CD16+/CD56+ but increased CD3+/CD8+ LSs (p<0.001). Finally, cesarean section was associated with significantly higher total CFU and CD16+/CD56+ but lower CD3+/CD4+, CD3+/CD8+, and CD19+ LSs.

These results provide a standard and range for uniformly processed HPC-C progenitor cells and LSs. CB progenitor cells and/or LSs may in the future predict for rapidity of engraftment, incidence of graft-versus-host disease, speed and quality of immuno-reconstitution, graft-versus-tumor effects, and/or success of gene transfection after CB transplantation.

3. Cord blood banking 2002: 112,010 of 7,914,773 chances. Rebulla P. Transfusion 2002; 42:1246-1248.

A summary of cord blood banking in 2002 indicated that 112,010 mothers have consented to donation of their newborns’ cord blood for long-term cryopreservation in 28 banking programs. Eight of these were in the US and 17 in Europe, which globally accounted for 55,560 and 44,693 units, respectively, or 49.6% and 39.9% of the total inventory. Also, there were 6449 units listed from Australia (5.8%) and 5238 from china (4.7%). More than 2300 allogeneic cord blood transplants have already been performed.

4. Racial and ethnic composition of volunteer cord blood donors: comparison with volunteer unrelated marrow donors. Ballen KK, Hicks J, Dharan B, Ambruso D, Anderson K, Bianco C et al. Transfusion 2002; 42:1279-1284.

A presumed advantage of cord blood is the ability to increase minority recruitment. However, a review of the racial composition of five member cord blood banks of the NMDP, representing 9020 cord blood donors, indicated that three of the cord blood banks recruited a lower percentage of minorities than the corresponding marrow donor centers. Further, four of the cord blood banks recruited a lower percentage of minorities compared with delivery data than the corresponding marrow donor centers compared with census population. The conclusion reached that the problem of insufficient minority recruitment of cord blood has not yet been solved.

5. An international survey of unrelated umbilical cord blood banking. Stanworth S, Warwick R, Fehily D, Persaud C, Armitage S, Navarrete C et al. Vox Sang 2001; 80:236-243.

This report presents the findings of an international survey of technical and operational aspects of cord blood banking. Nineteen cord blood banks were invited to participate in a postal survey regarding their practice in the 12-month period up to August 1998. A standardized questionnaire was designed to collect information about donor selection, collection, processing, testing, and storage of unrelated umbilical cord blood units. The survey revealed marked variations in cord blood banking practice and demonstrated a need for standardization. The authors suggested further similar surveys to ensure that stardards continued to develop to ensure the safety and quality of cord blood for all patients.

6. Racial diversity with high nucleated cell counts and CD34 counts achieved in a national network of cord blood banks. Ballen KK, Kurtzberg J, Lane TA, Lindgren BR, Miller JP, Nagan D, Newman B, Rupp N, Haley NR. Biol Blood Marrow Transplant. 2004;10:269-75.

A presumed advantage of cord blood is the ability to increase recruitment of donors of minority ethnic backgrounds. The American Red Cross Cord Blood Program was established in 1999 with 6 banks and 10 collection sites throughout the country. Racial designations were self-reported on questionnaires, and donor race was collected from each site. Postprocessing nucleated cell counts and CD34(+) counts were obtained on the cord blood units, and results from each racial/ethnic group (white, black, Asian, Hispanic, and Native American) were compared in the natural logarithmic scale by using analysis of variance. A total of 18878 donors consented: 64% white, 16% black, 12% Hispanic, 4% Asian, 1% Native American, and 3% other. Seven thousand eight hundred sixty-six cord blood units were banked for transplantation. The mean preprocessing nucleated cell count was 1220 x 10(6) (range, 327-7300 x 10(6)). There was no difference among racial groups when controlled for site. The mean CD34+ count was 3.28 x 10(6). Blacks had a significantly lower CD34+ count than the other racial/ethnic groups in the Midwest, Northwest, and North Carolina collection sites. The authors concluded that a racially diverse cord blood bank can be achieved. Nucleated cell counts were similar among the different racial/ethnic groups, although CD34+ counts were lower for blacks in some collection sites.