Department of Sports Medicine, The Sports Physicians Group, OLVG West, Amsterdam, The Netherlands.
Department of Orthopaedic Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
Br J Sports Med. 2017 Aug;51(15):1125-1133. doi: 10.1136/bjsports-2016-096793. Epub 2017 Mar 3.
Stem cell injection for knee osteoarthritis (KOA) is an emerging new therapy, and we aimed to review its evidence of efficacy.
Systematic review.
Criteria for eligibility were randomised controlled trials (RCTs) and non-RCT on the efficacy of stem cell injections in KOA. All references were checked for missed articles.
MEDLINE, EMBASE, CINAHL, Web of Science, Cochrane Library, PEDro and SPORTDiscus were searched. A grey literature search was performed. No restrictions were imposed to our search strategy.
Risk of bias was assessed using the Cochrane risk of bias tool. Descriptive synthesis was performed using the levels of evidence according to the Oxford Levels of Evidence.
Five RCTs and one non-RCT were found. Bone-marrow-derived stem cells, adipose-derived mesenchymal stem cells and peripheral blood stem cells were used. All trials were at high risk of bias, resulting in level-3 evidence. All five RCTs reported superior efficacy for patient-reported outcomes (Visual Analogue Scale, Western Ontario and McMaster Universities Arthritis Index, Tegner, Lysolm, International Knee Documentation Committee, Knee Injury and Osteoarthritis Outcome Score, Lequesne) compared with controls at final follow-up (range 24-48 months). Superior radiological outcomes were found favouring stem cell injection. Superior histological outcomes and/or improved arthroscopically scored healing rates were reported in two trials. No serious adverse events were reported.
Six trials with high risk of bias showed level-3 or level-4 evidence in favour of stem cell injections in KOA. In the absence of high-level evidence, we do not recommend stem cell therapy for KOA.
干细胞注射治疗膝骨关节炎(KOA)是一种新兴的治疗方法,本研究旨在评估其疗效证据。
系统评价。
纳入干细胞注射治疗 KOA 的随机对照试验(RCT)和非随机对照试验。对所有参考文献进行了检索,以避免遗漏相关文章。
MEDLINE、EMBASE、CINAHL、Web of Science、Cochrane Library、PEDro 和 SPORTDiscus 均被检索。同时还进行了灰色文献搜索。我们的检索策略没有任何限制。
使用 Cochrane 偏倚风险工具评估偏倚风险。根据牛津证据等级,使用证据水平进行描述性综合。
共发现 5 项 RCT 和 1 项非 RCT。使用的干细胞包括骨髓源性干细胞、脂肪源性间充质干细胞和外周血源性干细胞。所有试验均存在较高的偏倚风险,导致证据水平为 3 级。所有 5 项 RCT 均报告了在最终随访时(24-48 个月)患者报告的结局(视觉模拟评分、西安大略和麦克马斯特大学骨关节炎指数、Tegner、Lysholm、国际膝关节文献委员会、膝关节损伤和骨关节炎结果评分、Lequesne)的疗效优于对照组。影像学结果也显示出干细胞注射的优势。有 2 项试验报告了更好的组织学结果和/或改善了关节镜下评估的愈合率。未报告严重不良事件。
6 项高偏倚风险的试验提供了 3 级或 4 级证据,支持干细胞注射治疗 KOA。在缺乏高级别证据的情况下,我们不建议将干细胞疗法用于 KOA。