Abstract
Background
Umbilical cord blood (UCB) is an alternative source of hematopoietic stem cells (HSC) for transplantation of patients with hematologic malignancies or hereditary diseases.
Methods
We developed a provincial UCB bank in Guangzhou, China, using good manufacturing practices and standard operating procedures to address donor eligibility, collection, characterization, processing, storage and release from quarantine. The banking activities were analyzed.
Results
From June 1998 to May 2005, 8623 UCB units of Han ethnic origin were collected; 4147 (48.1%) were stored, while 4476 (51.9%) were discarded as a result of pre-determined exclusion criteria. A median volume of 95.5 mL (range 60–227.7) and 1.2×109 (0.8–9.3) nucleated cells were collected. The cell viability was 97.8% (90–100%). The CD34+ cell count of 3691 (89.0%) UCB units was 5.2×106 (0.3–131.6) and clonogenic assays of 4036 (97.3%) UCB units demonstrated 9.8×105 (0.04–135.8) CFU-GM, 0.3×105 (0.0–18.6) CFU-GEMM and 8.8×105 (0.0–74.2) BFU-E. A total of 0.4% (15/3863) UCB derived from babies known to have health problems at age 6 months was discarded. Up to May 2005, 151 units were issued for transplantation to 127 patients [90 (70.9%) children and 37 (29.1%) adults]. The infused nucleated cells in unrelated single-unit recipients were 3.4×107/kg (1.7–14.9) for adults (n=19) and 5.7×107/kg (2.0–20.5) for children (n=71), respectively. The numbers of days for the engraftment of neutrophils among 65 children and 22 adults were 17 (7–41) and 20 (10–42), respectively.
Discussion
Data of this study show that stringent procedures and comprehensive policies are requisite for pursuing the banking and release of quality UCB for successful transplantation.