Evaluation of Quality Parameters for Cord Blood Donations

Abstract

Background: Umbilical cord blood (CB) is widely used for hematopoietic stem cell transplantation and holds promise for the development of innovative medicinal products. In order to find out whether the conditions for collection and storage before processing might have an impact on the quality of CB preparations, viability and the clonogenic potential were assessed. Methods: CB was collected under field conditions. Flow cytometry was used to determine leukocytes, CD34/CD45+ cells, viability, and nucleated red blood cells (NRBC). Clonogenic activity was determined using isolated mononuclear cells (MNC). Results: Neither plasma citrate concentrations nor storage temperature (within 24 h) affected cell viability or colony formation. After storage for 49–80 h, leukocyte viability declined by about 16% compared to CB stored up to 24 h. In contrast, the clonogenic activity and CD34/CD45+ cell content were not affected. A higher gestational age was associated with a lower yield of clonogenic activity compared to midterm deliveries. NRBC varied widely (median 7.3%; range 0.63–17.3%) without relation to gestational age or colony formation. There was a close correlation between the percentage of viable CD34/CD45+ cells and colony formation (r = 0.77 for CFU-GM; r = 0.75 for CFU-C). Conclusions: The content of viable CD34/CD45+ cells represents the clonogenic activity of CB preparations. Therefore, determination of viable CD34/CD45+ cells should be generally performed as a routine quality control assay.

Factors which can influence the quality related to cell viability of the umbilical cord blood units

“…The extension of the time from collection to processing was associated with a decrease of cell viability. These findings are in accord with the results from other studies [5,6,13,21,26,27]. Some authors [28] considered that temperature is a key parameter and extended …”

“…Our conclusion is contradictory to the results of some authors who showed that the broad range of anticoagulant concentration did not affect cell viability, though a gradual loss of cell viability was observed after storage for 25-48 h and particular after 49-80 h [13]. But there are authors that suggest that the ratio of anticoagulant could determine low cell viability for the units with the collected UCB volume of less than 60 ml, even if the amount of anticoagulant in collection bags was lower (29 ml) [29].…”

“…There was no correlation between the time from collection to processing and the number of cells. Similar results have been reported by other authors [13,26]. However, some authors [33] have identified a reduced negative correlation between CD34 + cell count and the time from collection to processing.…”

“…According to our data there were good and very good positive correlations between collected UCB volume, TNCC and CD34 + cell count. Positive correlations between collected UCB volume and CD34 + cell count and between TNCC and CD34 + cell count were highlighted in other studies [13,14].…”

“…The controversial results show that UCB units must be stored before processing at 4°C [4][5][6][7] or at room temperature [8][9][10]. Other authors consider that there are no differences reflected in the quality of transplant units depending on the storage temperature [11][12][13].…”