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目的通过临床前动物实验评价,初步了解人源脐带间充质干细胞(human umbilical cord mesenchymal stem cells,h UMSCs)的生物安全性。方法选取小鼠、大鼠和裸鼠做为评价模型,使用不同剂量的h UMSCs进行评价,考察h UMSCs进入动物体内后的急性毒性反应、长期毒性反应以及致瘤性情况。结果急性毒性试验:在注射剂量不超过1.25×108个/kg时,血气学分析和剖解检测小鼠未呈现出毒性反应,h UMSCs的LD50和MTD分别为1.632×108个/kg、1.25×108个/kg。长期毒性试验:选取1.00×107个/kg、5.00×106个/kg和2.50×106个/kg三个剂量,进行12次静脉注射,观察6个月。受试大鼠注射后与对照组相比,在行为学、血气分析、血液指标检测和脏器系数比等方均未有异常变化。致瘤性试验:未有异常成瘤现象。结论本试验中,hUMSCs在受试动物体内未呈现出异常反应。
Objective To evaluate the bio-safety of human umbilical cord mesenchymal stem cells (h UMSCs) through preclinical animal experiments. Methods Mouse, rat and nude mice were selected as evaluation models and evaluated by different doses of hMSCs. The acute toxicity, long-term toxicity and tumorigenicity of hMSCs were investigated. Results Acute toxicity test: No toxic reaction was observed in hemodynamic analysis and anatomical examination at the dose of 1.25 × 108 / kg. The LD50 and MTD of h UMSCs were 1.632 × 108 / kg and 1.25 × 108, respectively A / kg. Long-term toxicity test: Select 1.00 × 107 / kg, 5.00 × 106 个 / kg and 2.50 × 106 / kg three doses, 12 intravenous injection, observed for 6 months. Compared with the control group, there was no abnormal change in behavioral science, blood gas analysis, blood test and organ coefficient ratio in the test rats after injection. Tumorigenicity test: no abnormal tumorigenesis. Conclusion In this experiment, hUMSCs showed no abnormal reaction in the test animals.