Evaluation of the Toxicity of Human Dental Pulp-Derived Mesenchymal Stem Cells on Animal Models: An Animal Study.

Introduction: Dental pulp remains one of the important sources of mesenchymal stem cells for most preclinical and clinical studies. Aim and Objectives: To assess the safety after injecting human dental pulp-derived mesenchymal stem cells by intramucosal and intrabony routes in rabbits for clinical application. Materials and Methods: Animal studies were carried out among 30 New Zealand male white rabbits (3-5 months old), weighing 1.5-2 kgs, which were divided into three groups with 10 animals in each group. Group 1: control group, Group 2: intramucosal route, Group 3: intrabony route. Data were analyzed using Student's t-test, and any P ≤ 0.05 was statistically significant. Results: A total of 30 rabbits were selected for the study, among which significant statistical difference for Packed cell volume (PCV) (P < 0.05), MCHC (P < 0.05), platelet count (P < 0.05), and ESR (p < 0.001) has been reported in the hematological parameters. The results of the present study indicate that the transplantation of hDPSCs by intramucosal and intrabony routes into a rabbit is non-toxic without any detectable side effects or local or systemic rejection. The pre-clinical safety and toxicity of the hDPSCs in various human disease models need to be determined in future studies. Various pre-clinical studies to determine the safety and toxicity of hDPSCs in human disease models have to be done in the future. Conclusion: This study showed that the intramucosal route and intrabony route of administration of stem cells were found to be non-toxic at 10 million per mL concentration. A further evaluation must be done for more definitive results.