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首页> 外文期刊>Trials >Autologous-cell-derived, tissue-engineered cartilage for repairing articular cartilage lesions in the knee: study protocol for a randomized controlled trial
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Autologous-cell-derived, tissue-engineered cartilage for repairing articular cartilage lesions in the knee: study protocol for a randomized controlled trial

机译：自体细胞衍生的组织工程软骨修复膝关节软骨病变：一项随机对照试验的研究方案

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Spontaneous recovery from articular cartilage injury is difficult, and the ongoing progression of disease can eventually lead to osteoarthritis. Currently, there is no effective non-surgical treatment for articular cartilage injury. Arthroscopic debridement and microfracture surgery are performed for fibrocartilage repair. But fibrocartilage is different from normal articular cartilage, and functional recovery is not satisfactory. Therefore, it is necessary to develop more effective techniques for articular cartilage repair. Progress in material science, cell biology, biomechanics, and bioreactor technology has allowed the development of biomimetic, tissue-engineered osteochondral composites that have shown potential for the repair of damaged cartilage. We prepared biomimetic, tissue-engineered cartilage scaffolds optimized for biochemical composition and structural characteristics. Based on the experience of our pre-clinical studies on animals, a human articular cartilage acellular matrix scaffold was prepared and is in clinical use. The combination of autologous chondrocytes and scaffolds has shown satisfactory results in repairing cartilage defects in preliminary experiments. This is a prospective randomized controlled trial. One hundred patients with full-thickness cartilage injury of the knee will be randomly divided into two groups to receive treatment with either tissue-engineered cartilage constructed using biomimetic cartilage extracellular-matrix-oriented scaffolds combined with autologous chondrocytes, or arthroscopic debridement and microfracture surgery. There will be five visiting time points: at baseline, then at 3, 6, 12, and 18?months postoperatively. The primary outcome will be therapeutic efficacy as assessed by the Lysholm score at 12?months postoperatively. The secondary outcomes will be the International Knee Documentation Committee score, Visual Analog Scale score, and cartilage injury and repair as assessed by magnetic resonance imaging as well as the incidence of postoperative adverse events. This trial will attempt to verify the use of tissue-engineered cartilage constructed using autologous chondrocytes combined with allogeneic, acellular cartilage matrix for the repair of cartilage defects, thereby providing favorable evidence for its use in clinical practice. ClinicalTrials.gov, identifier: NCT02770209 . Registered on 11 May 2016.
机译：从关节软骨损伤中自发恢复是困难的，疾病的持续发展最终会导致骨关节炎。目前，尚无有效的非手术治疗关节软骨损伤的方法。进行关节镜清创术和微骨折手术以修复纤维软骨。但是纤维软骨不同于正常的关节软骨，功能恢复也不令人满意。因此，有必要开发更有效的关节软骨修复技术。随着材料科学，细胞生物学，生物力学和生物反应器技术的发展，仿生，组织工程化的骨软骨复合材料的开发已显示出修复受损软骨的潜力。我们准备了仿生的，组织工程化的软骨支架，这些支架针对生化成分和结构特征进行了优化。基于我们对动物的临床前研究的经验，制备了人类关节软骨脱细胞基质支架，并将其用于临床。在初步实验中，自体软骨细胞和支架的组合在修复软骨缺损方面显示出令人满意的结果。这是一项前瞻性随机对照试验。一百例膝关节全层软骨损伤患者将被随机分为两组，接受仿生软骨细胞外基质导向支架结合自体软骨细胞构建的组织工程软骨治疗，或关节镜清创术和微骨折手术治疗。将有五个访问时间点：在基线，然后在术后3、6、12和18个月。术后12个月时通过Lysholm评分评估的主要结果将是治疗效果。次要结果将是国际膝关节文献委员会评分，视觉模拟量表评分以及通过磁共振成像评估的软骨损伤和修复以及术后不良事件的发生率。该试验将试图验证将自体软骨细胞与同种异体脱细胞软骨基质相结合构建的组织工程软骨在软骨缺损修复中的应用，从而为其在临床实践中的应用提供有利证据。 ClinicalTrials.gov，标识符：NCT02770209。 2016年5月11日注册。

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