Quality Control in Umbilical Cord Blood Bank / 中国实验血液学杂志

ABSTRACT

Recent clinical reports have demonstrated that the use of umbilical cord blood (UCB) opened a new source of stem cell for hematopoietic stem cell transplantation, leading to the development of cord blood banks world-wide. Prior to the large scale construction of UCB banks, quality control must be performed for health care providers and manufactures. With increasingly stringent regulatory requirement in blood industry, quality control is playing an important role in the operation of blood centers and stem cell laboratories. Reviewed the lectures in the biology of UCB and UCB banks published in recent years, our experiences were discussed in setting up Shandong blood bank to define process variables associated with the collection of UCB, to determine and optimize the procedures and materials used, to ascertain how UCB can be processed in clean room as mononucleated cell preparations, and to analyze using of long-term storage of UCB in research and clinic in the future. Our conclusions are (1) the establishment of UCB banks for use in transplantation appears to be easy, effective and particularly suitable approach in China under cGMP conditions; (2) the procedures for volume reduction by closed and semi-automated blood processing system, SSP HLA typing, biocode and local computer net, microbiological tests and the 50 ml cryobags for storage constitute a cost efficient system for large-scale UCB banking; (3) the average of 60 ml UCB collection may contain sufficent marrow repopulating cells for children and most of adult recipients; and (4) hematopoietic stem and progenitor cells in cord blood have a more potent proliferative ability than those derived from bone marrow in cell expansion potentials.