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A 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

Trial Profile

A 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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2023

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At a glance

  • Drugs Darvadstrocel (Primary)
  • Indications Fistula; Rectal fistula
  • Focus Registrational; Therapeutic Use
  • Acronyms ADMIRE-CD II
  • Sponsors TiGenix
  • Most Recent Events

    • 17 Oct 2023 According to a Takeda (Tigenix ) media release,Full results of the study will be presented at a future medical meeting or published in a peer-reviewed journal.
    • 17 Oct 2023 Results presented in the Takeda Media Release.
    • 17 Oct 2023 According to a Takeda (Tigenix ) media release,Primary endpoint of Percentage of Participants with Combined Remission at Week 24 has not been met.
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