Work

Results of the cord blood transplantation study (COBLT) unrelated donor banking program

Year: 2004

Type: article

Abstract: The COBLT banking program, initiated in 1996 with support from the National Heart Lung and Blood Institute aimed to 1) develop standard operating procedures (SOPs) for donor screening, recruitment and consenting and for collection, testing, processing, cryopreservation, and thawing of unrelated donor umbilical cord blood (UCB) and 2) build an ethnically diverse unrelated cord blood bank to support a transplantation research protocol. The program included multiple collection sites, 3 banks, a steering committee and coordinating center which developed a web based data collection system. Collections were initiated 12/97 and completed 7/2001. Screening data for 34,799 potential donors were collected from 4/98 to 3/2001. Of these 10,599 (30%) were not approached due to lack of informed consent or a COBLT exclusion criterion. A total 20,710 mothers (60% of screened) were approached and consented to participate in the program and UCB was collected from 48 % of those screened and 81% of those consented. 17,207 cord blood units (CBUs) of diverse ethnicity were collected (40% Caucasian; 17% African-American; 11% Asian; 20% Hispanic; 13% Mixed/Other). Of these, 11,096 (64%) were cryopreserved and placed in quarantine. Of these, 49% passed all eligibility criteria, were HLA-typed and entered into the COBLT search registry. The reasons for exclusion after collection were insufficient volume or cell count (64%), a positive maternal infectious disease test (8%) or a risk factor in the maternal history (8%). The mean total viable nucleated, CD34+, and CD3+ cell counts for the banked units were 9.2x10e8, 3.4x10e6 and 1.8x10e8, respectively. The mean total CFU-GM count was 9.3x10e5. Relationships between ethnicity, route of delivery, birth weight, maternal age, gestational age, infant gender and UCB yields in banked CBUs were examined. Higher cord blood volumes and total nucleated cell count (TNC) were obtained from C-section compared to vaginal deliveries. Units from African American donors contained lower TNC counts per volume compared to other ethnicities. UCB volume, TNC and CD34+ cell content correlated with birth weight. CD34+ content decreased with increasing gestational age. The COBLT Program demonstrates that SOPs for donor recruitment and consenting, collection, processing, cryopreservation, quality assurance, and data collection can be successfully developed and implemented in multiple banks coordinated by a single coordinating center.

Source: Transplantation and Cellular Therapy

DOI: 10.1016/j.bbmt.2003.12.082