猕猴静脉注射自体RAK细胞剂量安全性研究

Dose Security Experiment of Autologous RAK to Rhesus Monkeys through Intravenous Injection

目的通过对猕猴静脉注射自体RAK细胞,观察猕猴是否出现血管内细胞栓塞等现象,为评价在人体上回输RAK细胞安全性剂量提供依据。方法随机选择健康雄性猕猴5只,进行自体RAK细胞静脉回输,观察动物在回输过程中及回输结束后14d内动物的生理生化指标是否出现异常,是否出现血管栓塞现象。结果自体RAK细胞回输后至观察期14d结束,5只动物均存活,且精神状态良好,各动物的生理生化指标正常,无行为和体征异常出现。结论猕猴静脉注射自体RAK细胞达到拟用临床剂量上限时不会引起毒性反应,不会引起血管内栓塞现象。

Objective To supply safety dose of reinjection autologous RAK cells to rhesus monkeys through intravenous injection and observe whether embolism will occur. Method Selected five healthy male rhesus monkeys randomly and reinfused autologous RAK cells through intravenous injection. Then observe whether physiological index and biochemical indicator would appear abnormal, and whether embolism would occur during the injection and 14 days since then. Result All the five rhesus monkeys were survived and in good condition3 when the 14 days of observation was over. At the same time, the physiological index, biochemical indicator and physical sign of each monkey was normal, and behavior disorder did not occur among them. Conclusion No toxicity reaction or embolism were happened when rhesus monkeys were injected with upper limited clinical doses of autologous RAK.