目的 研究間充質(zhì)干細胞對小鼠的急性毒性作用, 初步探討其毒性反應(yīng), 為間充質(zhì)干細胞在臨床上安全使用提供指導(dǎo)。方法 選用ICR小鼠, 根據(jù)預(yù)試結(jié)果, 實驗分為3組:對照組和間充質(zhì)干細胞高、低劑量組, 每組分別采用20只實驗動物, 雌雄各半, 分別觀察小鼠對間充質(zhì)干細胞的反應(yīng)。結(jié)果 實驗期間, 各給藥組小鼠各檢查時間點平均體質(zhì)量與對照組比較均無明顯差異, 且小鼠被毛光澤, 精神狀態(tài)和自主活動均正常, 分泌物和排泄物等均未見明顯異常。表明間充質(zhì)干細胞制劑靜脈給藥對小鼠體質(zhì)量增長無明顯影響。與對照組比較, 間充質(zhì)干細胞低、高劑量組雄性小鼠脾、肺質(zhì)量及系數(shù)明顯升高, 高劑量組雌性大鼠肺臟系數(shù)明顯升高。結(jié)論 間充質(zhì)干細胞制劑無明顯的毒副作用, 且在肺臟和脾臟等部位滯留。

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.

重大新藥創(chuàng)制專項:重大疾病治療的干細胞藥物品種臨床試驗研究及其制藥工藝標準化研發(fā)(2014ZX09101042);子宮內(nèi)膜再生細胞藥物臨床前及臨床研究(2014ZX09101042-003)