Bone Engineering of Maxillary Sinus Bone Deficiencies Using Enriched CD90+ Stem Cell Therapy: A Randomized Clinical Trial
Bone Engineering of Maxillary Sinus Bone Deficiencies Using Enriched CD90+ Stem Cell Therapy: A Randomized Clinical Trial
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DOI：
10.1002/jbmr.2464
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发表时间：
2015-07-01
影响因子：
6.2
通讯作者：
Giannobile, William V.
中科院分区：
文献类型：
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作者：
Kaigler, Darnell;Avila-Ortiz, Gustavo;Giannobile, William V.
通过干细胞治疗局部颅面骨缺损或缺陷的骨工程为提高患者护理的治疗可预测性提供了强大的前景。这项1/2期随机对照临床试验的目的是评估用富含CD90+干细胞和CD14+单核细胞的自体细胞移植重建上颌窦骨缺损。30名需要上颌窦骨增强的人被招募。上颌窦有50% - 80%骨缺损的患者被随机分为两组，一组接受干细胞移植到磷酸三钙支架上，另一组接受单独支架。治疗4个月后，进行临床、影像学和组织学分析以评估新生工程骨。在获取牙槽骨核时，将口腔种植体安装在工程骨中，然后用牙义齿进行功能修复。放射学分析显示，治疗组之间获得的总骨量没有差异；然而，在接受干细胞治疗的患者中，工程骨的密度更高。骨核心活检显示，干细胞治疗在最严重的缺陷中提供了最大的益处，比对照组患者产生更好的骨质量，这可以通过更高的骨体积分数（BVF； 0.5对0.4;p=0.04）得到证明。评估CD90+干细胞富集程度与BVF的关系显示，移植细胞CD90含量越高，再生骨BVF越大（r=0.56; p=0.05）。在1年的随访中，所有患者均使用功能负载牙修复体放置和修复口腔种植体，无治疗相关不良事件报告。这些结果提供了证据，表明使用富集CD90+干细胞群的细胞疗法对上颌窦底重建是安全的，并有可能加速和提高其他颅面骨缺损和缺陷的组织工程骨质量。(c) 2015年美国骨与矿物研究学会。(c) 2015年美国骨与矿物研究学会
Bone engineering of localized craniofacial osseous defects or deficiencies by stem cell therapy offers strong prospects to improve treatment predictability for patient care. The aim of this phase 1/2 randomized, controlled clinical trial was to evaluate reconstruction of bone deficiencies of the maxillary sinus with transplantation of autologous cells enriched with CD90+ stem cells and CD14+ monocytes. Thirty human participants requiring bone augmentation of the maxillary sinus were enrolled. Patients presenting with 50% to 80% bone deficiencies of the maxillary sinus were randomized to receive either stem cells delivered onto a -tricalcium phosphate scaffold or scaffold alone. Four months after treatment, clinical, radiographic, and histologic analyses were performed to evaluate de novo engineered bone. At the time of alveolar bone core harvest, oral implants were installed in the engineered bone and later functionally restored with dental tooth prostheses. Radiographic analyses showed no difference in the total bone volume gained between treatment groups; however, density of the engineered bone was higher in patients receiving stem cells. Bone core biopsies showed that stem cell therapy provided the greatest benefit in the most severe deficiencies, yielding better bone quality than control patients, as evidenced by higher bone volume fraction (BVF; 0.5 versus 0.4; p=0.04). Assessment of the relation between degree of CD90+ stem cell enrichment and BVF showed that the higher the CD90 composition of transplanted cells, the greater the BVF of regenerated bone (r=0.56; p=0.05). Oral implants were placed and restored with functionally loaded dental restorations in all patients and no treatment-related adverse events were reported at the 1-year follow-up. These results provide evidence that cell-based therapy using enriched CD90+ stem cell populations is safe for maxillary sinus floor reconstruction and offers potential to accelerate and enhance tissue engineered bone quality in other craniofacial bone defects and deficiencies ( NCT00980278). (c) 2015 American Society for Bone and Mineral Research. (c) 2015 American Society for Bone and Mineral Research