【摘要】 近年来的临床报告表明 ,脐带血已为造血干细胞移植开辟了新的来源 ,从而导致了在世界范围内脐带血库的兴起。在建立大规模的脐带血库以前 ,制定质量控制标准对脐带血库及脐带血的临床应用是非常必要的。随着对有关血液制品生产企业的加强管理 ,质量控制在血液制品中心及造血干细胞实验室更是起着重要作用。我们根据近几年有关脐带血生物学特性及脐带血库发表的文献 ,结合着山东脐带血库脐带血采集的方法 ,脐带血在洁净车间的分离 ,以及为科研和临床应用的脐带血保存等经验 ,阐述对质量控制的要求。我们的结论是 :①按照cGMP的要求 ,在我国建立一座大型的脐带血库为临床移植应用 ,是完全可行的 ;②HES沉降去除红细胞 ,SSP组织相容性抗原 (HLA)配型 ,条形码和计算机联网 ,病毒及细菌检测以及采用 5 0毫升冰冻贮存袋保存脐带血是建立大型脐带血库的有效而经济的操作程序 ;③平均 60毫升脐带血含有足够的细胞为儿童及部分成人开展脐带血移植 ;④和骨髓血相比 ,脐带血造血干 祖细胞在体外扩增方面具有更大的潜力更多还原

【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.更多还原