SVF
Level A· Stronger Clinical EvidenceRandomized Controlled Trial

Darvadstrocel in Patients With Crohn's Disease With Complex Perianal Fistulas: The ADMIRE CD II Phase 3 Randomized Trial.

Colombel JF., Garcia Olmo D., Chen ST., Serclova Z., Schwartz DA., Wexner SD.

Randomized Controlled Trial with a reported sample of 283 on Autoimmune Research, published in Gastroenterology (2026) — summary generated from the PubMed abstract.

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Study type
Randomized Controlled Trial
Journal
Gastroenterology (2026)
Country
United States
Reported sample size
283
PMID
41790076
DOI
10.1053/j.gastro.2025.12.033
NCT
NCT03279081

Abstract (original English)

The ADMIRE CD trial demonstrated the efficacy and safety of darvadstrocel in patients with complex perianal fistulas from Europe and Israel. The efficacy and safety of darvadstrocel in an expanded patient population was investigated. ADMIRE CD II (ClinicalTrials.gov, Number: NCT03279081) was a phase 3, double-blind, randomized, placebo-controlled trial conducted in Europe, Israel, and North America. Adults with Crohn's disease and complex perianal fistulas with ≤2 internal openings and ≤3 external openings and inadequate response to immunosuppressive agents or biologics were randomized 1:1 to receive darvadstrocel (a dispersion of 120 × 10 6 stem cells in 24 mL sterile buffered solution) or placebo. Both groups underwent curettage and closure of the internal opening. The primary endpoint was combined remission (closure of all treated external openings and absence of collections >2 cm) at week 24. Overall, 568 patients were randomized to receive darvadstrocel (n = 283) or placebo (n = 285); 249 and 246, respectively, completed the trial. At week 24, combined remission was achieved in 138 of 283 (48.8%) patients in the darvadstrocel group and 132 of 285 (46.3%) in the placebo group (estimated treatment difference: 2.4%; 95% CI, -5.8 to 10.6; P = .571). There were no significant differences in key secondary endpoints for darvadstrocel vs placebo (clinical remission at week 24 [P =

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
HumansDouble-Blind MethodCrohn DiseaseFemaleAdultMaleRectal FistulaTreatment OutcomeRemission InductionMiddle Aged
Systemic / IVAutoimmune Research
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