Department of Periodontics and Oral Medicine, University of Michigan, Ann Arbor, MI, USA.
Cell Transplant. 2013;22(5):767-77. doi: 10.3727/096368912X652968.
Stem cell therapy offers potential in the regeneration of craniofacial bone defects; however, it has not been studied clinically. Tissue repair cells (TRCs) isolated from bone marrow represent a mixed stem and progenitor population enriched in CD90- and CD14-positive cells. In this phase I/II, randomized, controlled feasibility trial, we investigated TRC cell therapy to reconstruct localized craniofacial bone defects. Twenty-four patients requiring localized reconstruction of jawbone defects participated in this longitudinal trial. For regenerative therapy, patients were randomized to receive either guided bone regeneration (GBR) or TRC transplantation. At 6 or 12 weeks following treatment, clinical and radiographic assessments of bone repair were performed. Bone biopsies were harvested and underwent quantitative micro-computed tomographic (μCT) and bone histomorphometric analyses. Oral implants were installed, subsequently restored, and functionally loaded with tooth restorations. Reconstructed sites were assessed for 1 year following therapy. No study-related, serious adverse events were reported. Following therapy, clinical, radiographic, tomographic, and histological measures demonstrated that TRC therapy accelerated alveolar bone regeneration compared to GBR therapy. Additionally, TRC treatment significantly reduced the need for secondary bone grafting at the time of oral implant placement with a five fold decrease in implant bony dehiscence exposure (residual bone defects) as compared to GBR-treated sites(p < 0.01). Transplantation of TRCs for treatment of alveolar bone defects appears safe and accelerates bone regeneration, enabling jawbone reconstruction with oral implants. The results from this trial support expanded studies of TRC therapy in the treatment of craniofacial deformities (ClinicalTrials.gov number CT00755911).
干细胞疗法在颅面骨缺损的再生中具有潜力，但尚未在临床上进行研究。从骨髓中分离出的组织修复细胞（TRC）代表了一种混合的干细胞和祖细胞群体，富含 CD90 和 CD14 阳性细胞。在这项 I/II 期、随机、对照的可行性试验中，我们研究了 TRC 细胞疗法来重建局部颅面骨缺损。24 名需要局部重建颌骨缺损的患者参与了这项纵向试验。对于再生治疗，患者被随机分为接受引导骨再生（GBR）或 TRC 移植。在治疗后 6 或 12 周，对骨修复进行临床和放射学评估。采集骨活检标本，并进行定量微计算机断层扫描（μCT）和骨组织形态计量学分析。随后安装口腔种植体，并进行修复和功能加载牙修复体。治疗后 1 年评估重建部位。未报告与研究相关的严重不良事件。治疗后，临床、放射学、断层扫描和组织学测量表明，与 GBR 治疗相比，TRC 治疗加速了牙槽骨再生。此外，与 GBR 治疗部位相比，TRC 治疗显著降低了在口腔种植体放置时进行二次骨移植的需求，种植体骨暴露（残留骨缺损）减少了五倍（p < 0.01）。TRC 移植治疗牙槽骨缺损似乎是安全的，并能加速骨再生，从而能够用口腔种植体重建颌骨。该试验的结果支持进一步研究 TRC 疗法在颅面畸形治疗中的应用（ClinicalTrials.gov 编号 CT00755911）。
