Mesenchymal stem cell-derived exosomes for complex perianal fistula ‒ A systematic review and single-arm
Fang Cheng1, Xia Chen1, Ying Liao1
1Gastroenterology, The Sixth People's Hospital of Chengdu, China.
Objectives:
We performed a single-arm meta-analysis to evaluate the efficacy and safety of MSC-Exos in the treatment of complex PFs.
Methods:
This systematic review followed PRISMA guidelines and included studies published up to March 20, 2025. We searched four databases for studies evaluating efficacy and/or safety of MSC-Exos for complex PFs. Analyses were performed using R statistical software version 4.4.0.
Results:
The analysis of three studies included in this study suggested that MSC-Exos were effective in achieving complete healing in 57% of patients with complex PFs (95% confidence interval (CI) 0.43, 0.76). The pooled data further indicated that MSC-Exos could achieve complete healing in 68% of complex fistula tracts (95% CI 0.59, 0.80). Pooled analysis also showed that 86% (95% CI 0.75,0.98) of patients with complex PFs achieved clinical response post treatment, whereas 18% (95% CI 0.09, 0.37) demonstrated no clinical response after MSC-Exos treatment. Subgroup analysis revealed a higher healing rate (HR) in patients with Crohn's disease (CD) compared to those without CD (60% vs. 57%, respectively), with no statistically significant differences (P > 0.05). Notably, neither systemic nor local adverse effects have been reported in any study.
Conclusion:
This meta-analysis highlights the efficacy and safety of local administration of MSC-Exos in patients with complex PFs, offering valuable evidence to guide future clinical practice.
Insights
Mesenchymal stem cell-derived exosomes (MSC-Exos) show promise in treating complex perianal fistulas (PFs). This meta-analysis found MSC-Exos effective for healing and clinical response, with no reported adverse effects.
Area of Science:
- Regenerative Medicine
- Gastroenterology
- Surgical Innovation
Background:
- Complex perianal fistulas (PFs) present a significant therapeutic challenge.
- Existing treatments for complex PFs have limitations in efficacy and safety.
- Mesenchymal stem cell-derived exosomes (MSC-Exos) are emerging as a potential novel therapeutic agent.
Purpose of the Study:
- To evaluate the efficacy and safety of MSC-Exos for the treatment of complex PFs.
- To synthesize current evidence on MSC-Exos in complex PF management.
- To provide data to guide future clinical applications of MSC-Exos.
Main Methods:
- A single-arm meta-analysis was conducted.
- Systematic review followed PRISMA guidelines, searching four databases.
- Included studies evaluated MSC-Exos for efficacy and/or safety in complex PFs.
Main Results:
- MSC-Exos achieved complete healing in 57% of patients with complex PFs.
- Complete healing of fistula tracts was observed in 68% of cases.
- 86% of patients showed clinical response, with no reported adverse events.
Conclusions:
- Local administration of MSC-Exos demonstrates significant efficacy and safety in treating complex PFs.
- MSC-Exos offer a promising therapeutic option for complex fistula management.
- This meta-analysis provides valuable evidence supporting the use of MSC-Exos in clinical practice.
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