Słynarski Knee Clinic, Warsaw, Poland.
Cartilage Repair Systems, LLC, New York, New York, USA.
Am J Sports Med. 2020 May;48(6):1327-1337. doi: 10.1177/0363546520912444. Epub 2020 Apr 8.
There is an unmet need for a single-stage cartilage repair treatment that is cost-effective and chondrocyte-based.
To evaluate the safety and preliminary efficacy of autologous freshly isolated primary chondrocytes and bone marrow mononucleated cells (MNCs) seeded into a PolyActive scaffold in patients with symptomatic cartilage lesions of the knee.
Case series; Level of evidence, 4.
A total of 40 patients with symptomatic knee cartilage lesions were treated with freshly isolated autologous chondrocytes combined with bone marrow MNCs delivered in a biodegradable load-bearing scaffold. The treatment requires only 1 surgical intervention and is potentially a cost-effective alternative to autologous chondrocyte implantation. The primary chondrocytes and bone marrow MNCs were isolated, washed, counted, mixed, and seeded into a load-bearing scaffold in the operating room. Patients were followed up at 3, 6, 12, 18, and 24 months. Primary endpoints were treatment-related adverse events up to 3 months, adverse implant effects between 3 and 24 months, and the implant success rate at 3 months as measured by lesion filling.
Successful lesion filling (≥67% on magnetic resonance imaging) was found in 40 patients at 3 months and in 32 of the 32 patients analyzed at 24 months. Significant improvement over baseline was found for visual analog scale for pain from 3 months onward; Knee injury and Osteoarthritis Outcome Score (KOOS)-Pain and KOOS-Activities of Daily Living from 6 months onward; for KOOS-Symptoms and Stiffness, KOOS-Quality of Life and International Knee Documentation Committee from 12 months onward; and for KOOS-Sport and Recreation from 18 months onward. Hyaline-like repair tissue was found in 22 of 31 patients available for biopsy. Arthralgia and joint effusion were the most common adverse events. Scaffold delamination and adhesions led to removal of the implant in 2 patients.
The treatment of knee cartilage lesions with autologous primary chondrocytes and bone marrow MNCs, both isolated and seeded into a load-bearing PolyActive scaffold within a single surgical intervention, is safe and clinically effective. Good lesion fill and sustained clinically important and statistically significant improvement in all patient-reported outcome scores were found throughout the 24-month study. Hyaline-like cartilage was observed on biopsy specimen in at least 22 of the 40 patients.
NCT01041885 (ClinicalTrials.gov identifier).
目前需要一种单阶段的软骨修复治疗方法，这种方法既具有成本效益，又基于软骨细胞。
评估自体新鲜分离的原代软骨细胞和骨髓单个核细胞（MNC）接种于 PolyActive 支架治疗膝关节有症状软骨损伤患者的安全性和初步疗效。
病例系列；证据水平，4 级。
共 40 例膝关节有症状软骨损伤患者接受新鲜分离的自体软骨细胞联合骨髓 MNC 治疗，使用可生物降解的负重支架输送。该治疗仅需 1 次手术干预，是自体软骨细胞移植的潜在经济有效的替代方法。在手术室中，将原代软骨细胞和骨髓 MNC 分离、洗涤、计数、混合并接种到负载支架上。患者在 3、6、12、18 和 24 个月时进行随访。主要终点是 3 个月内与治疗相关的不良事件、3 至 24 个月间的不良植入物效应，以及 3 个月时通过病变填充测量的植入物成功率。
在 3 个月时，40 例患者中有 40 例成功实现病变填充（磁共振成像≥67%），在 32 例可分析的患者中有 32 例在 24 个月时成功实现病变填充。从 3 个月开始，视觉模拟评分（VAS）疼痛评分、膝关节损伤和骨关节炎结果评分（KOOS）-疼痛和 KOOS-日常活动评分、6 个月开始 KOOS-症状和僵硬评分、KOOS-生活质量和国际膝关节文献委员会评分、12 个月开始 KOOS-运动和娱乐评分均有显著改善。22 例可供活检的患者中有 22 例发现类透明软骨修复组织。最常见的不良事件是关节痛和关节积液。2 例患者因支架分层和粘连导致植入物取出。
采用自体原代软骨细胞和骨髓 MNC 治疗膝关节软骨病变，两者均在单次手术干预中分离并接种到负载 PolyActive 支架中，是安全且临床有效的。在整个 24 个月的研究中，所有患者报告的结果评分均发现病变填充良好，持续具有重要的临床意义和统计学意义的改善。在至少 40 例患者中的 22 例患者的活检标本中观察到类透明软骨。
NCT01041885（ClinicalTrials.gov 标识符）。
