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. 2025 Mar 28;16(1):152.
doi: 10.1186/s13287-025-04272-y.

Efficacy of mesenchymal stem cell-based therapies in the treatment of perianal fistulizing Crohn's disease: a systematic review and meta-analysis

Lucas Guillo  1   2 , Robinson Gravier Dumonceau  3 , Mélanie Vélier  4   5 , Mélanie Serrero  6 , Fanny Grimaud  7 , Florence Sabatier  4   5 , Jérémy Magalon  4   5
Affiliations

Efficacy of mesenchymal stem cell-based therapies in the treatment of perianal fistulizing Crohn's disease: a systematic review and meta-analysis

Lucas Guillo et al. Stem Cell Res Ther. .

Abstract

Background: Perianal lesions of Crohn's disease (CD) are complex and disabling conditions. Mesenchymal stem cell (MSC)-based therapies have emerged as an innovative approach in managing refractory perianal fistulizing CD. We conducted a systematic review and meta-analysis to describe and compare combined remission and clinical outcomes of MSC-based therapies, and then whether one approach stands out from the rest.

Methods: We searched in MEDLINE, EMBASE and CENTRAL (up to December 31, 2023) all prospective studies assessing a local injection of MSC-based therapy in perianal fistulas of CD. The primary outcome was achievement of combined remission. MSC-based therapy strategies were compared.

Results: Twenty-five studies were included in the meta-analysis, enrolling 596 patients with perianal fistulizing CD. The combined remission rate at 3, 6 and 12 months were 36.2% (95% confidence interval (CI), 24.5-49.7), 57.9% (95% CI 51.3-64.2) and 52% (95% CI 38.8-64.8), respectively. MSC-based therapies demonstrated a significant effect in achieving combined remission compared to placebo at 3 months (relative risk (RR) = 1.6; 95% CI 1.0-2.8) and at 6 months (RR = 1.5; 95% CI 1.1-1.9). At 6 months, the combined remission rate was 57.2% (95% CI 47.2-66.6) for adipose-derived stem cells (ASCs) and 55.7% (95% CI 26.4-81.5) for bone marrow-derived stem cells (BMSCs). In the network meta-analysis, allogeneic ASCs and BMSCs did not demonstrate superiority over each other (RR = 0.74; 95% CI 0.31-1.77).

Conclusion: MSC-based therapies are effective for achieving combined remission of refractory and/or complex perianal fistulizing CD. The optimal efficacy effect is reached after 6 months of treatment. No superiority has yet been demonstrated between ASCs and BMSCs therapies.

Keywords: Crohn’s disease; Fistula; Mesenchymal stem cells; Meta-analysis; Stromal vascular fraction.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: All authors have given their consent for publication. Competing interests: L Guillo received lecture and/or consulting fees from Abbvie, Amgen, Ferring and Janssen. JM received honorarium for educational support from Fidia, Horiba and Macopharma. The remaining authors declare no conflict of interest.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram
Fig. 2
Fig. 2
Risk of bias assessment using the Cochrane risk of bias tool, version 2.0 (RoB 2)
Fig. 3
Fig. 3
Forest plot comparing the fistula combined remission rate after treatment with MSC-based therapy. A Combined remission at 3 months, B Combined remission at 6 months, C Combined remission at 12 months
Fig. 4
Fig. 4
Forest plot comparing risk ratio for achieving combined remission of fistula after treatment with MSC-based therapy in randomized controlled trials. A Combined remission at 3 months, B Combined remission at 6 months
Fig. 5
Fig. 5
Forest plot comparing the fistula clinical and combined remission rate after treatment with BMSCs or ASCs. A Clinical remission with BMSCs at 6 months, B Clinical remission with ASCs at 6 months, C Combined remission with BMSCs at 6 months, D Combined remission with ASCs at 6 months. ASC Adipose-derived stem cell, BMSC Bone marrow-derived stem cell
See this image and copyright information in PMC

References

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