Thapaswini Yekula, Phanindra S, Ramavarapu Avinash, Kudala Venkata Raman, Cherukuri Sai Abhishiktha
Department of Prosthodontics, Sri Sai College of Dental Surgery, Vikarabad, Telangana, India.
Department of Prosthodontics, Meghna Institute of Dental Sciences, Nizamabad, Telangana, India.
J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S683-S687. doi: 10.4103/jpbs.jpbs_84_22. Epub 2022 Jul 13.
Dental pulp remains one of the important sources of mesenchymal stem cells for most preclinical and clinical studies.
To assess the safety after injecting human dental pulp-derived mesenchymal stem cells by intramucosal and intrabony routes in rabbits for clinical application.
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 -test, and any ≤ 0.05 was statistically significant.
A total of 30 rabbits were selected for the study, among which significant statistical difference for Packed cell volume (PCV) ( < 0.05), MCHC ( < 0.05), platelet count ( < 0.05), and ESR ( < 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.
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.
对于大多数临床前和临床研究而言,牙髓仍是间充质干细胞的重要来源之一。
评估通过黏膜内和骨内途径向兔体内注射人牙髓来源的间充质干细胞用于临床应用后的安全性。
对30只3至5个月大、体重1.5至2千克的新西兰雄性白兔进行动物研究,将其分为三组,每组10只动物。第1组:对照组;第2组:黏膜内途径组;第3组:骨内途径组。数据采用学生t检验进行分析,任何p≤0.05具有统计学意义。
共选择30只兔子进行研究,血液学参数中报道了血细胞比容(PCV)(p<0.05)、平均血红蛋白浓度(MCHC)(p<0.05)、血小板计数(p<0.05)和红细胞沉降率(ESR)(p<0.001)存在显著统计学差异。本研究结果表明,通过黏膜内和骨内途径将人牙髓干细胞移植到兔体内是无毒的,没有任何可检测到的副作用或局部或全身排斥反应。人牙髓干细胞在各种人类疾病模型中的临床前安全性和毒性需要在未来的研究中确定。未来必须进行各种临床前研究以确定人牙髓干细胞在人类疾病模型中的安全性和毒性。
本研究表明,在每毫升1000万个细胞的浓度下,干细胞的黏膜内途径和骨内途径给药是无毒的。必须进行进一步评估以获得更明确的结果。