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Pulp regeneration by transplantation of dental pulp stem cells in pulpitis: a pilot clinical study

机译:牙髓炎中通过牙髓干细胞移植进行牙髓再生的临床试验研究

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Background Experiments have previously demonstrated the therapeutic potential of mobilized dental pulp stem cells (MDPSCs) for complete pulp regeneration. The aim of the present pilot clinical study is to assess the safety, potential efficacy, and feasibility of autologous transplantation of MDPSCs in pulpectomized teeth. Methods Five patients with irreversible pulpitis were enrolled and monitored for up to 24?weeks following MDPSC transplantation. The MDPSCs were isolated from discarded teeth and expanded based on good manufacturing practice (GMP). The quality of the MDPSCs at passages 9 or 10 was ascertained by karyotype analyses. The MDPSCs were transplanted with granulocyte colony-stimulating factor (G-CSF) in atelocollagen into pulpectomized teeth. Results The clinical and laboratory evaluations demonstrated no adverse events or toxicity. The electric pulp test (EPT) of the pulp at 4?weeks demonstrated a robust positive response. The signal intensity of magnetic resonance imaging (MRI) of the regenerated tissue in the root canal after 24?weeks was similar to that of normal dental pulp in the untreated control. Finally, cone beam computed tomography demonstrated functional dentin formation in three of the five patients. Conclusions Human MDPSCs are safe and efficacious for complete pulp regeneration in humans in this pilot clinical study.
机译:背景技术先前的实验已经证明了动员牙髓干细胞(MDPSC)对于完全牙髓再生的治疗潜力。本临床试验研究的目的是评估在切除牙髓的牙齿中自体移植MDPSC的安全性,潜在疗效和可行性。方法纳入5例不可逆性牙髓炎患者,并在MDPSC移植后进行长达24周的监测。从废弃的牙齿中分离出MDPSC,并根据良好生产规范(GMP)对其进行扩展。通过核型分析确定在第9或10代的MDPSC的质量。 MDPSCs与端粒胶原蛋白中的粒细胞集落刺激因子(G-CSF)一起移植到切除了牙髓的牙齿中。结果临床和实验室评估均未显示不良反应或毒性。纸浆在4周时的电纸浆测试(EPT)显示出强劲的阳性反应。 24周后,根管中再生组织的磁共振成像(MRI)信号强度与未处理对照组的正常牙髓相似。最后,锥形束计算机断层扫描显示了五名患者中三名的功能性牙本质形成。结论在这项初步临床研究中,人类MDPSC对人类完整的牙髓再生是安全有效的。

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