Complex perianal fistula is a highly debilitating and difficult to treat condition. Local mesenchymal stem cell (MSC) therapy for perianal fistula has shown considerable promise but still remains controversial. Therefore, we performed the meta-analysis to evaluate the efficacy and safety of local MSC therapy for complex perianal fistula. PubMed and Embase databases were searched for published randomized clinical trials (RCTs) that reported local MSC therapy for complex perianal fistulas. The effectiveness and safety data analysis was conducted using RevMan5.3. Subgroup analyses were performed based on the characteristics of the studies. Seven RCTs with 730 participants were included. Local MSC treatment showed significantly higher healing rate (HR) of perianal fistulas compared to control (odds ratio (OR) = 2.03; 95% confidence interval (CI) 1.50, 2.74; ). MSCs combined with fibrin glue therapy can improve the HR compared with fibrin glue alone (; 95% CI 1.15, 9.28; ). Subgroup analyses showed that local therapy can improve the HR in patients with perianal fistulas associated with Crohn’s disease (CD) (; 95% CI 1.41, 3.00; ) and cryptoglandular origin (no-Crohn) (; 95% CI 0.86, 10.29; ). The pooled OR for studies that combined reepithelialization of the external opening with pelvic magnetic resonance imaging (MRI) to evaluate the healing of fistulas was 1.77 (95% CI 1.28, 2.45; ). The pooled OR for studies where fistula healing was defined as complete reepithelialization of external openings was 5.92 (95% CI 1.34, 26.15; ). Both autologous MSCs (; 95% CI 1.05, 9.65; ) and allogeneic MSCs (; 95% CI 1.34, 2.91; ) can obtain higher HR for perianal fistula compared with control. The adipose-derived MSC group can obtain higher HR than the control group (; 95% CI 1.38, 3.79; ). There were no significant differences in adverse events (AEs) (; 95% CI 0.71, 1.59; ). None of the adverse events was judged to be related to MSCs. Our study supported that local MSC therapy alone or combined with fibrin glue is safe and efficacious for complex perianal fistula. In the future, more RCTs are needed to confirm this conclusion.

中文翻译：

---

间充质干细胞治疗复杂性肛周瘘管的疗效和安全性：一项荟萃分析

复杂的肛周瘘管极易使人衰弱，难以治疗。肛周瘘管局部间充质干细胞（MSC）治疗已显示出可观的前景，但仍存在争议。因此，我们进行了荟萃分析，以评估局部MSC治疗复杂性肛周瘘管的疗效和安全性。搜索PubMed和Embase数据库以查找已发表的随机临床试验（RCT），该试验报告了局部MSC治疗复杂的肛周瘘管。使用RevMan5.3进行有效性和安全性数据分析。根据研究的特征进行亚组分析。包括730名参与者的7个RCT。与对照相比，局部MSC治疗显示肛周瘘管的治愈率（HR）明显更高（优势比（OR）= 2.03； 95％置信区间（CI）为1.50，）。与单独使用纤维蛋白胶相比，MSC结合纤维蛋白胶治疗可改善心率（; 95％CI 1.15，9.28;）。亚组分析表明，局部治疗可改善伴有克罗恩病（CD）的肛周瘘管患者的HR（; 95％CI 1.41，3.00;）和隐腺起源（no-Crohn）（; 95％CI 0.86，10.29;）。将外部开口的再上皮化与盆腔磁共振成像（MRI）相结合以评估瘘管愈合的研究的合并OR为1.77（95％CI 1.28，2.45;）。将瘘管愈合定义为外部开口完全再上皮化的研究的合并OR为5.92（95％CI 1.34，26.15;）。两种自体MSC（; 95％CI 1.05，9.65;）和同种异体MSC（; 95％CI 1.34，2.91;）与对照组相比，肛周瘘管可以获得更高的HR。脂肪来源的MSC组可以获得比对照组更高的HR（; 95％CI 1.38，3.79;）。不良事件（AE）没有显着差异（; 95％CI 0.71，1.59;）。没有不良事件被判定与MSC相关。我们的研究支持局部MSC单独治疗或与纤维蛋白胶联合治疗对于复杂的肛周瘘管是安全有效的。将来，需要更多的RCT来确认该结论。