肛瘘是一种发病率高、治愈困难的结直肠肛门外科疾病，一般采取切开、挂线手术治疗，但是存在恢复时间长、复发率高、治疗效果欠佳等问题。近年来，外科治疗技术不断向精准化、微创化、再生化方向发展。间充质干细胞（MSCs）因具有多向分化潜能和强大的旁分泌能力，被公认为理想的组织再生及修复的药物。此前大量MSCs的临床试验验证了MSCs治疗难治性复杂性肛瘘安全有效。但目前国际上MSCs治疗肛瘘的相关研究仍处于探索阶段，多为小样本回顾性研究且观察时间短，对MSCs治疗肛瘘的机制认识不足，且手术方式多样，缺乏统一标准化的临床手术规范。本文通过Pubmed、clinicaltrials.gov、国内万方、知网数据库等，收集了2003~2024年MSCs治疗肛瘘的临床试验文献，就国内外MSCs手术方式、使用剂量、临床研究结果、治疗效果、存在的问题和发展前景作一综述。

Anal fistula is a colorectal anorectal surgical disease with a high incidence and difficult cure, generally treated by incision or seton procedures, but issues such as long recovery time, high recurrence rate, and poor treatment outcomes exist. In recent years, surgical treatment technologies have continually evolved towards precision, minimization, and regenerative directions. Mesenchymal stem cells (MSCs), recognized for their multipotent differentiation potential and robust paracrine abilities, are acknowledged as ideal for tissue regeneration and repair. Extensive clinical trials of MSCs have proven their safety and efficacy in treating complex, refractory anal fistulas. The current international research on the treatment of anal fistulas with MSCs is still in the exploratory stage. Most studies are small-scale, retrospective, and short-term, leading to a limited understanding of the mechanisms by which MSCs treat anal fistulas. Additionally, there is a diversity of surgical approaches being used, and there is a lack of standardized clinical surgical protocols. This article compiles clinical trial literature from 2003 to 2024 on the treatment of anal fistulas with MSCs, gathered from databases such as PubMed, clinicaltrials.gov, Wanfang, and CNKI. It provides a comprehensive review of domestic and international surgical methods, dosages used, clinical research outcomes, treatment effectiveness, existing challenges, and prospects for development.