University of California Irvine School of Medicine, Irvine, California.
Department of Orthopaedic Surgery, Keck School of Medicine of USC, Los Angeles, California.
J Bone Joint Surg Am. 2019 Jan 16;101(2):186-195. doi: 10.2106/JBJS.17.01474.
The prospect of treating knee cartilage injury/pathology with mesenchymal stem cells (MSCs) has garnered considerable attention in recent years, but study heterogeneity and a lack of randomized controlled trials (RCTs) preclude quantitative analysis. The purpose of this review was to provide clinicians with an overview of RCTs that addresses 2 key areas that have been largely overlooked: nomenclature inconsistency and selective outcome reporting.
RCTs that purported to use stem cells or MSCs to treat knee cartilage were identified with use of PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses). Study variables were compiled, and methodological quality was assessed. The cell treatments and the methods used to characterize them were recorded and compared. Clinical, radiographic, and arthroscopic outcomes were extracted and evaluated qualitatively.
There was extensive variation among the treatments, adjuvant therapies, and outcome measures. Treatments did not coincide with terminology. Significant differences in clinical outcomes were reported infrequently, and intra-group improvements or inter-group subscore differences were consistently highlighted, particularly when inter-group comparisons were left unreported.
Overall, there are isolated cases in which positive efficacy results have been published, but our results suggest that the generally positive efficacy conclusions concerning stem cell therapy for knee cartilage pathology may be overstated. Nevertheless, it is important to understand that the efficacy of stem cell therapies should not be considered in aggregate. Cells that are procured or processed differently produce entirely different drugs. When evaluating the efficacy of "stem cell" therapies, clinicians must consider the methodological quality, nomenclature, and inherent distinctness of each treatment.
近年来，用间充质干细胞（MSCs）治疗膝关节软骨损伤/病变的前景引起了广泛关注，但研究的异质性和缺乏随机对照试验（RCT）排除了定量分析。本综述的目的是为临床医生提供 RCT 的概述，重点关注两个在很大程度上被忽视的关键领域：命名不一致和选择性结果报告。
使用 PRISMA（系统评价和荟萃分析的首选报告项目）确定了据称使用干细胞或 MSCs 治疗膝关节软骨的 RCT。编译了研究变量，并评估了方法学质量。记录并比较了细胞治疗方法及其特征的方法。提取并定性评估临床、放射学和关节镜检查结果。
治疗方法、辅助疗法和结局测量之间存在广泛的差异。治疗方法与术语不一致。很少报告临床结局的显著差异，并且经常突出显示组内改善或组间亚评分差异，特别是当未报告组间比较时。
总体而言，有孤立的案例发表了阳性疗效结果，但我们的结果表明，关于干细胞治疗膝关节软骨病变的一般阳性疗效结论可能被夸大了。然而，重要的是要理解，不应将干细胞疗法的疗效综合考虑。获取或处理方式不同的细胞会产生完全不同的药物。在评估“干细胞”疗法的疗效时，临床医生必须考虑每种治疗方法的方法学质量、命名和固有独特性。
