Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)

Phase 3 Completed 568 enrolled Tigenix S.A.U.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (\>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.

Timeline

Start: 2017-09-15
Primary completion: 2023-01-23
Completion: 2023-07-26

Outcome

Missed primary endpoint

paper ADMIRE CD II did not meet its primary endpoint of combined remission at week 24, with no statistically significant difference between darvadstrocel and placebo. PMID 41790076 ↗

registry analysis (superiority test); Placebo vs Cx601; p =0.571; Difference in Combined Remission Rate 2.37 (95% CI -5.82 to 10.55) NCT03279081 ↗

Publications

Colombel JF, Garcia Olmo D, Chen ST, Serclova Z, Schwartz DA, Wexner SD, Panes J, Wu C, Zhang B, Song M, McKay C, Nazarey P, Wright E, Raffals L, Fleshner P. Darvadstrocel in Patients With Crohn's Disease With Complex Perianal Fistulas: The ADMIRE CD II Phase 3 Randomized Trial. Gastroenterology. 2026 Jun;170(7):1562-1570. doi: 10.1053/j.gastro.2025.12.033. Epub 2026 Mar 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darvadstrocel	Cell therapy	120 cells	Other