同种异体脐带血来源间充质干细胞联合透明质酸复合物植入对比微骨折术治疗膝骨关节炎：5年软骨修复更持久且临床结局更优
简介
这项III期试验的回顾性子集分析从原始89例中纳入64例Kellgren-Lawrence I–III级膝骨关节炎患者（48例完成5年随访），比较同种异体脐带血来源间充质干细胞-透明质酸复合物（UCB-MSCs-HA）植入与微骨折术。5年时UCB-MSCs-HA组VAS（23.4 vs 46.3，P=0.0019）、WOMAC（21.8 vs 37.7，P=…
英文摘要
PURPOSE: To compare the 5-year clinical and magnetic resonance imaging (MRI) outcomes of allogeneic umbilical cord blood-derived mesenchymal stem cells and hyaluronate (UCB-MSCs-HA) composite implantation versus microfracture in osteoarthritic knees and to evaluate factors associated with durable repair tissue. METHODS: This retrospective subset analysis of a phase 3 trial included patients with Kellgren-Lawrence grade I to III osteoarthritis who were treated with allogeneic UCB-MSCs-HA implantation or microfracture and completed serial MRI and clinical evaluations up to 5 years postoperatively. Clinical outcomes included the visual analog scale, the Western Ontario and McMaster Universities Osteoarthritis Index, and International Knee Documentation Committee scores. MRI outcomes were assessed using the Magnetic Resonance Observation of Cartilage Repair Tissue score at 3 and 5 years. Durable repair was defined as Magnetic Resonance Observation of Cartilage Repair Tissue >60 at both evaluations with <10-point interval change. RESULTS: Of the 89 patients in the original trial, 64 were included, and 48 completed the 5-year follow-up. At 5 years, UCB-MSCs-HA showed better visual analog scale (23.4 [0-69] vs 46.3 [7-90]; P = .0019), Western Ontario and McMaster Universities Osteoarthritis Index (21.8 [0-70] vs 37.7 [3-79]; P = .016), and International Knee Documentation Committee scores (59.4 [20.7-95.4] vs 46.5 [13.8-75.9]; P = .014) than microfracture. Minimal clinically important difference achievement rates were higher with UCB-MSCs-HA for visual analog scale (50.0% vs 28.1%; P = .123), Western Ontario and McMaster Universities Osteoarthritis Index (53.1% vs 28.1%; P = .074), and International Knee Documentation Committee (56.3% vs 31.3%; P = .077) but were not significant. Lower limb alignment was not associated with clinical or MRI outcomes, and Magnetic Resonance Observation of Cartilage Repair Tissue scores did not differ between groups. Durable repair was more frequent with UCB-MSCs-HA (62.5% vs 26.3%, P = .031), and UCB-MSCs-HA was the only factor associated with durable repair (odds ratio 8.2, 95% confidence interval 1.6-42.5, P = .012). CONCLUSIONS: Allogeneic UCB-MSCs-HA implantation showed better clinical outcomes and a higher proportion of MRI-defined durable repair tissue at 5 years compared with microfracture in osteoarthritic knees. LEVEL OF EVIDENCE: Level III, therapeutic retrospective comparison study.