Objective. To evaluate minimum biosecurity parameters (MBP) for arthroscopic matrix-encapsulated autologous chondrocyte implantation (AMECI) based on patients' clinical outcomes, magnetic resonance imaging (MRI) T2-mapping, Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and International Cartilage Repair Society (ICRS) second-look arthroscopic evaluation, laying the basis for a future multicenter study. Design. Pilot clinical study. We analyzed the logistics to perform AMECI to treat focal chondral lesions in different hospitals following strict biosecurity parameters related to tissue and construct transportation, chondrocyte isolation, and cell expansion. Patient progress was analyzed with patient-reported outcome measures, MRI T2-mapping, MOCART, and ICRS arthroscopic second-look evaluation. Results. Thirty-five lesions in 30 patients treated in 7 different hospitals were evaluated. Cell viability before implantation was >90%. Cell viability in construct remnants was 87% ± 11% at 24 hours, 75% ± 17.1% at 48 hours, and 60% ± 8% at 72 hours after implantation. Mean final follow-up was 37 months (12-72 months). Patients showed statistically significant improvement in all clinical scores and MOCART evaluations. MRI T2-mapping evaluation showed significant decrease in relaxation time from 61.2 ± 14.3 to 42.9 ± 7.2 ms (P < 0.05). Arthroscopic second-look evaluation showed grade II "near normal" tissue in 83% of patients. Two treatment failures were documented. Conclusions. It was feasible to perform AMECI in 7 different institutions in a large metropolitan area following our biosecurity measures without any implant-related complication. Treated patients showed improvement in clinical, MRI T2-mapping, and MOCART scores, as well as a low failure rate and a favorable ICRS arthroscopic evaluation at a mid-term follow-up. Level of Evidence. 2b.

中文翻译：

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关节镜基质包裹自体软骨细胞植入：拉丁美洲的试点多中心调查。

客观的。根据患者的临床结果、磁共振成像 (MRI) T2 映射、软骨修复组织的磁共振观察 (MOCART) 评分和国际标准评估关节镜基质包裹自体软骨细胞植入 (AMECI) 的最低生物安全参数 (MBP)软骨修复协会 (ICRS) 二次关节镜评估，为未来的多中心研究奠定了基础。设计。试点临床研究。我们按照与组织和构建体运输、软骨细胞分离和细胞扩增相关的严格生物安全参数分析了执行 AMECI 以治疗不同医院的局灶性软骨损伤的后勤工作。通过患者报告的结果测量、MRI T2 映射、MOCART 和 ICRS 关节镜二次评估来分析患者进展。结果。对在 7 家不同医院接受治疗的 30 名患者的 35 个病灶进行了评估。植入前的细胞存活率>90%。在植入后 24 小时，构建残余物中的细胞活力为 87% ± 11%，在 48 小时为 75% ± 17.1%，在 72 小时为 60% ± 8%。平均最终随访时间为 37 个月（12-72 个月）。患者在所有临床评分和 MOCART 评估中均显示出统计学上的显着改善。MRI T2 映射评估显示弛豫时间从 61.2 ± 14.3 显着减少至 42.9 ± 7.2 ms (P < 0.05)。关节镜二次评估显示 83% 的患者组织为 II 级“接近正常”。记录了两次治疗失败。结论。按照我们的生物安全措施，在大都市地区的 7 个不同机构进行 AMECI 是可行的，没有任何与植入物相关的并发症。接受治疗的患者在临床、MRI T2 映射和 MOCART 评分方面表现出改善，以及在中期随访中的低失败率和良好的 ICRS 关节镜评估。证据水平。2b。