中文摘要：

目的将冻存的人脐带间充质干细胞（US-MSCs）制备成一种复苏后可直接用于临床的制剂，并进行质量检定。方法从种子细胞库复苏冻存的UC-MSCs，待细胞培养至P3代时，收集UC-MSCs，按照4×10^7，剂的规格加入含5％人血白蛋白、10％DMSO、85％复方电解质溶液的细胞保护液，形成制剂，并对其进行质量检定，包括无菌检测、支原体检测、细胞内外源致病因子检测、内毒素检测、免疫表型检测、稳定性检测、异常免疫学反应检测以及残留物检测。结果制备的UC-MSCs制剂无菌、无支原体污染，无内外致病因子，毒素〈2EU，能抑制异源淋巴细胞的增殖，抑制率随脐带间充质干细胞数量增加而增大。牛血清残留〈50ng，袋，制剂冻存前细胞活性〉90％，复苏后活性〉85％。结论按照此方法制备的UC-MSCs制剂符合临床治疗要求的质量检定标准。

英文摘要：

Objective To prepare the cryopreserved umbilical cord mesenchymal stem cells （UC-MSCs） into a kind of preparation that can be directly clinically used upon the resuscitation and to test the quality. Methods The cryopreserved UC-MSCs from the seed cell bank were resuscitated and collected when cultivated to P3-generation. The cell protective fluid containing 5% human serum albumin （HSA）, 10%DMSO and 85% compound electrolyte solution with a specification of 4×10^7/agent was added to form the preparation, the quality of which was tested, including sterility test, mycoplasma detection, internal and external pathogenic factor detection, endotoxin detection, immune phenotype detection, stability detection, abnormal immune response detection and residue detection. Results The UC-MSCs preparation thus prepared was sterile without mycoplasma contamination or internal and external pathogenic factors, with poison 〈 2 EU. It could inhibit the proliferation of allogeneic lymphocytes, with the inhibition ratio increasing with the increase of the number of UC-MSCs. Bovine serum residue 〈 50 ng/bag; the cell activity of the preparation before cryopreservation 〉 90%; the cell activity after the resuscitation 〉 85%. Conclusion The UC-MSCs preparation thus prepared is up to the quality test standard for clinical treatment.