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Repair of Torn Avascular Meniscal Cartilage Using Undifferentiated Autologous Mesenchymal Stem Cells:From In Vitro Optimization to a First-in-Human Study

机译:使用未分化的自体间充质干细胞修复撕裂的半月板软骨:从体外优化到首次人类研究

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摘要

Meniscal cartilage tears are common and predispose to osteoarthritis. Most occur in the avascular portion of the meniscus where current repair techniques usually fail. We described previously the use of undifferentiated autologous mesenchymal stem cells (MSCs) seeded onto a collagen scaffold (MSC/collagen-scaffold) to integrate meniscal tissues in vitro. Our objective was to translate this method into a cell therapy for patients with torn meniscus, with the long-term goal of delaying or preventing the onset of osteoarthritis. After in vitro optimisation, we tested an ovine-MSC/collagen-scaffold in a sheep meniscal cartilage tear model with promising results after 13 weeks, although repair was not sustained over 6 months. We then conducted a single centre, prospective, open-label first-in-human safety study of patients with an avascular meniscal tear. Autologous MSCs were isolated from an iliac crest bone marrow biopsy, expanded and seeded into the collagen scaffold. The resulting human-MSC/collagen-scaffold implant was placed into the meniscal tear prior to repair with vertical mattress sutures and the patients were followed for 2 years. Five patients were treated and there was significant clinical improvement on repeated measures analysis. Three were asymptomatic at 24 months with no MRI evidence of recurrent tear and clinical improvement in knee function scores. Two required subsequent meniscectomy due to re-tear or non-healing of the meniscal tear at approximately 15 months after implantation. No other adverse events occurred. We conclude that undifferentiated MSCs could provide a safe way to augment avascular meniscal repair in some patients. Registration: EU Clinical Trials Register, 2010-024162- 22.
机译:半月板软骨撕裂很常见,易患骨关节炎。多数发生在半月板的无血管部分,目前的修复技术通常会失败。我们先前描述了使用未分化的自体间充质干细胞(MSCs)播种到胶原蛋白支架(MSC /胶原蛋白支架)上体外整合半月板组织的方法。我们的目标是将这种方法转变为半月板撕裂患者的细胞疗法,其长期目标是延迟或预防骨关节炎的发作。经过体外优化后,我们在绵羊半月板软骨撕裂模型中测试了绵羊-MSC /胶原蛋白支架,并在13周后获得了可喜的结果,尽管修复未持续6个月以上。然后,我们对无血管性半月板撕裂的患者进行了一项单中心,前瞻性,开放标签的人用安全性研究。自an骨髓活检中分离自体MSC,扩增并接种到胶原蛋白支架中。将所得的人MSC /胶原蛋白支架植入物放入半月板撕裂中,然后用垂直床垫缝合线修复,并对患者进行随访2年。对五名患者进行了治疗,并且通过重复措施分析获得了明显的临床改善。 3例在24个月无症状,没有MRI证据表明复发撕裂和膝关节功能评分临床改善。植入后约15个月,由于再次撕裂或半月板撕裂未愈合,需要进行两次半月板切除。没有其他不良事件发生。我们得出的结论是,未分化的MSC可以为某些患者提供增强血管半月板修复的安全方法。注册:欧盟临床试验注册,2010-024162- 22。

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