SVF
Level A· Stronger Clinical EvidenceMeta-analysis

Darvadstrocel for complex perianal fistulas in Crohn's disease: A systematic review and meta-analysis.

Taxonera C., García-Brenes MA., Olivares D., López-García ON., Zapater R., Alba C.

Meta-analysis with a reported sample of 595 on Autoimmune Research, published in United European Gastroenterol J (2025) — summary generated from the PubMed abstract.

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Meta-analysis
Journal
United European Gastroenterol J (2025)
Country
England
Reported sample size
595
PMID
39360706
DOI
10.1002/ueg2.12673

Abstract (original English)

Local injection of darvadstrocel, a suspension of expanded adipose-derived allogenic mesenchymal stem cells, has been used for treatment-refractory perianal fistulas in Crohn's disease (CD). This study aimed to investigate efficacy and safety of darvadstrocel for complex perianal fistulas in CD. A systematic search was conducted through April 2024 in relevant databases for observational studies evaluating darvadstrocel. A random-effects meta-analysis model was used to calculate the pooled effect sizes (proportions or incidence rates [IRs]) with 95% confidence intervals (CIs) of effectiveness and safety outcomes. The risk of bias was evaluated using the Joanna Briggs Institute Critical Appraisal Tool. The I 2 value assessed heterogeneity. Sensitivity and subgroup analyses were also conducted. Twelve studies were included with 595 patients. The pooled rate of patients achieving clinical remission, defined as fistula healing, was 68.1% at month 6 (95% CI 63.4-72.7) and 77.2% (95% CI 70.1-83.8) at month 12. Combined remission, defined as clinical remission and absence of collections >2 cm confirmed by magnetic resonance imaging, was reported in 60.6% and in 69.7% of patients at months 6 and 12, respectively. The rate of patients with treatment failure, defined as no clinical remission at the last follow-up (mean 18.7 months; SD 9.9), was 34.5%. Failure rate was independent of follo

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

How we grade evidence
HumansCrohn DiseaseRectal FistulaTreatment OutcomeMesenchymal Stem Cell TransplantationRemission Induction
Systemic / IVAutoimmune Research
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