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[摘要]
目的 研究间充质干细胞对小鼠的急性毒性作用, 初步探讨其毒性反应, 为间充质干细胞在临床上安全使用提供指导。方法 选用ICR小鼠, 根据预试结果, 实验分为3组:对照组和间充质干细胞高、低剂量组, 每组分别采用20只实验动物, 雌雄各半, 分别观察小鼠对间充质干细胞的反应。结果 实验期间, 各给药组小鼠各检查时间点平均体质量与对照组比较均无明显差异, 且小鼠被毛光泽, 精神状态和自主活动均正常, 分泌物和排泄物等均未见明显异常。表明间充质干细胞制剂静脉给药对小鼠体质量增长无明显影响。与对照组比较, 间充质干细胞低、高剂量组雄性小鼠脾、肺质量及系数明显升高, 高剂量组雌性大鼠肺脏系数明显升高。结论 间充质干细胞制剂无明显的毒副作用, 且在肺脏和脾脏等部位滞留。
[Key word]
[Abstract]
Objective To observe the acute toxicity of mesenchymal stem cell (MSC) in ICR mice, discuss the toxicity, and provide a basis for safe and reasonable medication in clinic. Methods the mice were divided into three groups (20 in each group, male and female), they were high-dose of MSC group, low-dose of MSC group, and normal saline (NS) group. And then all the cells were tested respectively by the classic methods for the acute toxicity in ICR mice. Results There was no evident difference in the weight and the mood of mice among the three groups. But compared with the NS group, the weight and weight index of the spleen and lung in male mice were obviously increased in the high-dose group and low-dose group. Besides, the weight index of lung in female mice was increased evidently. Conclusion There is no obvious side-effect after administrating MSC.
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[基金项目]
重大新药创制专项:重大疾病治疗的干细胞药物品种临床试验研究及其制药工艺标准化研发(2014ZX09101042);子宫内膜再生细胞药物临床前及临床研究(2014ZX09101042-003)