Cho Woo Sup, Chung Sun Gun, Kim Won, Jo Chris H, Lee Shi-Uk, Lee Sang Yoon
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Ann Rehabil Med. 2021 Aug;45(4):274-283. doi: 10.5535/arm.21078. Epub 2021 Aug 30.
To evaluate the efficacy and safety of mesenchymal stem cells (MSCs) therapy in patients with tendon disorders enrolled in prospective clinical studies.
We systematically searched prospective clinical studies that investigated the effects of MSC administration on human tendon disorders with at least a 6-month follow-up period in the PubMed-MEDLINE, EMBASE, and Cochrane Library databases. The primary outcome of interest was the change in pain on motion related to tendon disorders. Meta-regression analyses were performed to assess the relationship between MSC dose and pooled effect sizes in each cell dose.
Four prospective clinical trials that investigated the effect of MSCs on tendon disorders were retrieved. MSCs showed a significant pooled effect size (overall Hedges' g pooled standardized mean difference=1.868; 95% confidence interval, 1.274-2.462; p<0.001). The treatment with MSCs improved all the aspects analyzed, namely pain, functional scores, radiological parameters (magnetic resonance image or ultrasonography), and arthroscopic findings. In the meta-regression analysis, a significant cell dose-dependent response in pain relief (Q=9.06, p=0.029) was observed.
Our meta-analysis revealed that MSC therapy may improve pain, function, radiological, and arthroscopic parameters in patients with tendon disorders. A strong need for large-scale randomized controlled trials has emerged to confirm the long-term functional improvement and adverse effects of MSC therapies in tendon disorders.
评估间充质干细胞(MSCs)疗法对纳入前瞻性临床研究的肌腱疾病患者的疗效和安全性。
我们在PubMed-MEDLINE、EMBASE和Cochrane图书馆数据库中系统检索了前瞻性临床研究,这些研究调查了MSCs给药对人类肌腱疾病的影响,随访期至少为6个月。主要关注的结局是与肌腱疾病相关的运动时疼痛的变化。进行Meta回归分析以评估每个细胞剂量下MSCs剂量与合并效应量之间的关系。
检索到四项研究MSCs对肌腱疾病影响的前瞻性临床试验。MSCs显示出显著的合并效应量(总体Hedges' g合并标准化均差=1.868;95%置信区间,1.274-2.462;p<0.001)。MSCs治疗改善了所有分析的方面,即疼痛、功能评分、放射学参数(磁共振成像或超声检查)和关节镜检查结果。在Meta回归分析中,观察到疼痛缓解存在显著的细胞剂量依赖性反应(Q=9.06,p=0.029)。
我们的Meta分析表明,MSCs疗法可能改善肌腱疾病患者的疼痛、功能、放射学和关节镜检查参数。迫切需要进行大规模随机对照试验,以证实MSCs疗法对肌腱疾病的长期功能改善和不良反应。