Safety Assessment of Human Bone Marrow-derived Mesenchymal Stromal Cells Transplantation in Wistar Rats.

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 30th 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.