Aithal Ashwini P, Bairy Laxminarayana Kurady, Seetharam Raviraja N
Senior Grade Lecturer, Department of Anatomy, Melaka Manipal Medical College, Manipal University, Manipal, Karnataka, India.
Professor, Department of Pharmacology, RAK College of Medical Sciences, RAK Medical and Health Sciences University, Ras Al Khaimah, United Arab Emirates.
J Clin Diagn Res. 2017 Sep;11(9):FF01-FF03. doi: 10.7860/JCDR/2017/29515.10534. Epub 2017 Sep 1.
INTRODUCTION: Bone Marrow-derived Mesenchymal Stromal Cells (BM-MSCs) are multipotent stem cells isolated from adult human bone marrow. Properties of MSCs make them potentially ideal candidates for regenerative medicine. The preclinical data available in the literature regarding the safety assessment of MSCs at different dosage group is scanty. AIM: To evaluate the safety of BM-MSCs transplantation in Wistar rats. MATERIALS AND METHODS: Eighteen adult female Wistar rats were used in the study. They were randomly divided into normal control, low dose MSCs and high dose MSCs groups. Low dose group received 3.25 million BM-MSCs/kg body weight; high dose group received 9.75 million BM-MSCs/kg body weight intravenously. Body weight, food and water intake of each rat were measured statistically using SPSS version 16.0; animals were observed for changes in behaviour, general clinical signs, presence of any abnormal response, mortality for thirty days. RESULTS: Repeated measures ANOVA indicated a significant increase in body weight, food, and water intake of all animals at all weeks of the study period compared to week zero (p<0.05). Between the low dose and high dose MSCs group, increase in absolute body weight was seen at the end of the 30 day which was statistically significant (p=0.01). There was no significant difference in body weights, food and water intake in MSCs group when compared to normal control. All the animals survived for the entire duration of the study. Further, there was no change in the behaviour of the animals, no adverse clinical signs or complications following the MSCs treatment. CONCLUSION: Results indicate that administration of BM-MSCs is safe when given by a slow intravenous infusion as it did not alter the food and water intake behaviour of the animals and did not have any negative effect on its body weight.
引言:骨髓间充质基质细胞(BM-MSCs)是从成年人类骨髓中分离出来的多能干细胞。间充质干细胞的特性使其成为再生医学中潜在的理想候选者。文献中关于不同剂量组间充质干细胞安全性评估的临床前数据很少。 目的:评估BM-MSCs移植到Wistar大鼠中的安全性。 材料与方法:本研究使用了18只成年雌性Wistar大鼠。它们被随机分为正常对照组、低剂量间充质干细胞组和高剂量间充质干细胞组。低剂量组静脉注射325万个BM-MSCs/kg体重;高剂量组静脉注射975万个BM-MSCs/kg体重。使用SPSS 16.0版本对每只大鼠的体重、食物和水摄入量进行统计学测量;观察动物30天内的行为变化、一般临床体征、是否存在任何异常反应及死亡率。 结果:重复测量方差分析表明,与第0周相比,在研究期间的所有周,所有动物的体重、食物和水摄入量均显著增加(p<0.05)。在低剂量和高剂量间充质干细胞组之间,30天结束时绝对体重增加,具有统计学意义(p=0.01)。与正常对照组相比,间充质干细胞组的体重、食物和水摄入量没有显著差异。所有动物在整个研究期间均存活。此外,动物的行为没有变化,间充质干细胞治疗后没有不良临床体征或并发症。 结论:结果表明,通过缓慢静脉输注给予BM-MSCs是安全的因为它没有改变动物的食物和水摄入行为,并且对其体重没有任何负面影响。
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