脱细胞组织工程透明软骨移植物（dLhCG）用于关节软骨修复的临床研究
简介
这项前瞻性首次人体探索性临床研究将脱细胞组织工程透明软骨移植物（dLhCG）植入17例全层膝关节软骨缺损（Outerbridge III/IV）患者，术后18个月内可见移植物与周围原生组织稳定整合，临床结局评分及MOCART评分显著改善；MRI T2 mapping以修复组织与邻近健康软骨的回波时间比值评估，结果接近1，提示透明样生化和结构特征。未报告严重临…
英文摘要
Current clinical approaches for knee cartilage repair are often limited by hypertrophy and fibrosis in the regenerated tissues. A decellularized tissue-engineered hyaline cartilage graft (dLhCG), composed of a type II collagen-based extracellular matrix, has been developed to overcome this limitation. Extensive preclinical studies have demonstrated the ability of dLhCG to achieve hyaline cartilage repair and maintain a stable hyaline phenotype. In this prospective, first-in-human, exploratory clinical study (ChiCTR2400094194, ChiCTR2500100526, and ChiCTR2500105847), dLhCG was implanted to treat full-thickness knee articular cartilage defects (Outerbridge grade III/IV) in 17 patients. Stable graft integration with the surrounding native tissue was observed up to 18 months postoperatively. Significant improvements were noted in clinical outcome scores and MOCART scores. MRI T2 mapping evaluated as the ratio of repair-tissue echo time to adjacent healthy cartilage, yielded values approaching 1, suggesting hyaline-like biochemical and structural characteristics. No serious clinical adverse events were reported; asymptomatic imaging abnormalities, including bone marrow edema, were noted in some cases. These findings provide preliminary evidence of the feasibility, short-term safety, and encouraging outcomes of dLhCG for hyaline-like cartilage repair, warranting further investigation in controlled clinical trials.