Last updated on April 2019

Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease


Brief description of study

The purpose of this phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre 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 patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study

Detailed Study Description

The current multicentre phase III study is proposed to evaluate the efficacy and safety of Cx601 compared to placebo for the treatment of complex perianal fistula(s) in patients with Crohn's disease at Week 24 with a follow-up period up to 52 weeks.

The primary efficacy analysis, will be conducted at Week 24 timepoint. The double blind design will be maintained up to Week 52 (both patient and investigator) by a specific blinding for study treatment administration and for evaluating its efficacy .

The study will follow an add-on design, patients receiving any ongoing concomitant medical treatment, at stable doses at the time of screening, for the Crohn's disease (CD) will be allowed to continue it throughout the study.

Study treatments will be allocated, on a 1:1 ratio, by central randomization through interactive web response system (IWRS).

Clinical Study Identifier: NCT03279081

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