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首页> 外文期刊>BMJ Open >Adipose derived mesenchymal stem cell therapy in the treatment of isolated knee chondral lesions: design of a randomised controlled pilot study comparing arthroscopic microfracture versus arthroscopic microfracture combined with postoperative mesenchymal stem cell injections
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Adipose derived mesenchymal stem cell therapy in the treatment of isolated knee chondral lesions: design of a randomised controlled pilot study comparing arthroscopic microfracture versus arthroscopic microfracture combined with postoperative mesenchymal stem cell injections

机译：脂肪来源的间充质干细胞疗法治疗孤立的膝软骨损伤：比较关节镜下微骨折与关节镜下微骨折联合术后间充质干细胞注射的随机对照试验设计

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Introduction The management of intra-articular chondral defects in the knee remains a challenge. Inadequate healing in areas of weight bearing leads to impairment in load transmission and these defects predispose to later development of osteoarthritis. Surgical management of full thickness chondral defects include arthroscopic microfracture and when appropriate autologous chondrocyte implantation. This latter method however is technically challenging, and may not offer significant improvement over microfracture. Preclinical and limited clinical trials have indicated the capacity of mesenchymal stem cells to influence chondral repair. The aim of this paper is to describe the methodology of a pilot randomised controlled trial comparing arthroscopic microfracture alone for isolated knee chondral defects versus arthroscopic microfracture combined with postoperative autologous adipose derived mesenchymal stem cell injections. Methods and analysis A pilot single-centre randomised controlled trial is proposed. 40 participants aged 18–50?years, with isolated femoral condyle chondral defects and awaiting planned arthroscopic microfracture will be randomly allocated to a control group (receiving no additional treatment) or treatment group (receiving postoperative adipose derived mesenchymal stem cell treatment). Primary outcome measures will include MRI assessment of cartilage volume and defects and the Knee Injury and Osteoarthritis Outcome Score. Secondary outcomes will include further MRI assessment of bone marrow lesions, bone area and T2 cartilage mapping, a 0–10 Numerical Pain Rating Scale, a Global Impression of Change score and a treatment satisfaction scale. Adverse events and cointerventions will be recorded. Initial outcome follow-up for publication of results will be at 12?months. Further annual follow-up to assess long-term differences between the two group will occur. Ethics and dissemination This trial has received prospective ethics approval through the Latrobe University Human Research Ethics Committee. Dissemination of outcome data is planned through both national and international conferences and formal publication in a peer-reviewed journal. Trial registration number Australia and New Zealand Clinical Trials Register (ANZCTR Trial ID: ACTRN12614000812695). Study design This will be a single centre pilot randomised controlled trial. An overview of the process of the trial is presented in figure 1. View larger version: In a new window Download as PowerPoint Slide Setting Assessment for inclusion into the study will be conducted at the Melbourne Stem Cell Centre, Melbourne, Australia. Participants randomised to the treatment group will undergo all treatment at this location. The treatment will include a liposuction stem cell harvest and postarthroscopy stem cell injections. Arthroscopy and microfracture will be performed within the hospitals where the referring orthopaedic surgeon has formal accreditation. The arthroscopy forms part of the accepted standard treatment of the participant and is external to the study. The arthroscopy will be performed by the referring surgeon and will not be limited to a single surgeon.
机译：引言膝关节软骨内缺损的处理仍然是一个挑战。负重区域的愈合不足会导致负荷传递受损，而这些缺陷会导致以后发生骨关节炎。全层软骨缺损的外科治疗包括关节镜微骨折和适当时自体软骨细胞植入。然而，后一种方法在技术上具有挑战性，并且可能无法提供相对于微裂缝的显着改善。临床前和有限的临床试验表明，间充质干细胞影响软骨修复的能力。本文的目的是描述比较单独的关节镜显微骨折与孤立的膝关节软骨缺损与关节镜显微骨折联合术后自体脂肪来源的间充质干细胞注射的先导性随机对照试验的方法。方法与分析提出了一项单中心随机对照试验。 40名年龄在18至50岁之间，具有孤立的股骨con软骨缺损并等待计划中的关节镜微骨折的参与者将被随机分配至对照组（不接受额外治疗）或治疗组（接受术后脂肪来源的间充质干细胞治疗）。主要的结局指标包括对软骨体积和缺损的MRI评估以及膝关节损伤和骨关节炎结果评分。次要结果将包括进一步的MRI评估骨髓损伤，骨面积和T2软骨图，0-10数字疼痛评分量表，总体变化印象评分和治疗满意度量表。不良事件和共同干预将被记录。公布结果的初步结果随访时间为12个月。将进行进一步的年度随访以评估两组之间的长期差异。伦理和传播该试验已通过拉特罗布大学人类研究伦理委员会获得了预期的伦理批准。计划通过国内和国际会议以及在同行评审期刊上正式发表来分发结果数据。试验注册号澳大利亚和新西兰临床试验注册（ANZCTR试验ID：ACTRN12614000812695）。研究设计这将是单中心试验的随机对照试验。图1给出了该试验过程的概述。查看大图：在新窗口中以PowerPoint幻灯片设置下载评估要包括在研究中，将在澳大利亚墨尔本的墨尔本干细胞中心进行。随机分配到治疗组的参与者将在此位置接受所有治疗。治疗将包括抽脂干细胞收获和关节镜检查后干细胞注射。关节镜和微骨折将在推荐的整形外科医生获得正式认可的医院内进行。关节镜检查是参与者公认的标准治疗的一部分，并且在研究之外。关节镜检查将由转诊外科医生进行，并且不限于单个外科医生。

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