Cui Cunbao, Lin Feng, Xia Liang, Zhang Xinguang
Department of Joint Surgery, Central Hospital Affiliated to Shandong First Medical University, NO. 105, Jiefang Road, Jinan, 250013, China.
Department of Thoracic Surgery, Central Hospital Affiliated to Shandong First Medical University, NO. 105, Jiefang Road, Jinan, 250013, China.
BMC Musculoskelet Disord. 2025 Mar 12;26(1):245. doi: 10.1186/s12891-025-08365-w.
This meta-analysis aimed to pool the existing evidence to determine the clinical efficacy and safety of mesenchymal stem cells (MSC) in patients with non-unions.
A systematic search in PubMed and Scopus was performed until October 2024 to gather pertinent studies. The inclusion criteria included participants with non-unions, the intervention of MSC administration, a comparator of standard treatment (bone graft), and outcomes focused on healing rate, healing time, or side effects. The Jadad score Newcastle-Ottawa Scale (NOS) was used to assess the risk of bias in randomized and non-randomized studies, respectively. Moreover, GRADE criteria were used to assess the quality of evidence. Using a random effects model, odds ratios (OR) with 95% confidence intervals (CIs) were calculated for healing and complication rates, while standardized mean differences (SMD) with their 95% CIs were used to assess the impact of MSC therapy on bone union time.
Twenty-one studies, with 866 patients, were included. The bone healing rates were 44% at 3 months, 73% at 6 months, 90% at 9 months, and 86% at 12 months, eventually reaching 91% after 12 months of follow-up. MSC therapy, with or without scaffolds, was linked to higher odds of bone healing rate at 3 and 6 months, compared to bone grafts as the standard care (OR = 1.69). The time to union following the treatment was 6.30 months (95%CI: 86-96%), with patients treated with MSC/Scaffold experiencing a shorter time compared to MSC alone (5.85 vs. 6.36 months). MSC therapy significantly decreased bone union time (SMD:-0.54 months, 95% CI: -0.75 to -0.33). The complication rate was 1% (MSC/Scaffold: 0%, MSC alone: 2%), with MSC alone or MSC/Scaffold showing a lower risk than the standard care (OR = 0.41, 95% CI: 0.22-0.78).
MSC is a potential adjunct therapy for patients with non-union fractures.
Not applicable.
本荟萃分析旨在汇总现有证据，以确定间充质干细胞（MSC）治疗骨不连患者的临床疗效和安全性。
截至2024年10月，在PubMed和Scopus上进行了系统检索，以收集相关研究。纳入标准包括骨不连患者、MSC给药干预、标准治疗（骨移植）对照以及以愈合率、愈合时间或副作用为重点的结局。分别使用Jadad评分和纽卡斯尔-渥太华量表（NOS）评估随机和非随机研究中的偏倚风险。此外，采用GRADE标准评估证据质量。使用随机效应模型，计算愈合率和并发症率的比值比（OR）及其95%置信区间（CI），同时使用标准化均数差（SMD）及其95%CI评估MSC治疗对骨愈合时间的影响。
纳入21项研究，共866例患者。3个月时骨愈合率为44%，6个月时为73%，9个月时为90%，12个月时为86%，随访12个月后最终达到91%。与作为标准治疗的骨移植相比，无论有无支架的MSC治疗在3个月和6个月时骨愈合率的优势更高（OR = 1.69）。治疗后的愈合时间为6.30个月（95%CI：86 - 96%），接受MSC/支架治疗的患者愈合时间比单独使用MSC的患者短（5.85个月对6.36个月）。MSC治疗显著缩短了骨愈合时间（SMD：-0.54个月，95%CI：-0.75至-0.33）。并发症发生率为1%（MSC/支架：0%，单独使用MSC：2%），单独使用MSC或MSC/支架的风险低于标准治疗（OR = 0.41，95%CI：0.22 - 0.78）。
MSC是骨不连骨折患者的一种潜在辅助治疗方法。
不适用。
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