A Phase III, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess Efficacy and Safety of Expanded Allogeneic Adipose-derived Stem Cells (eASCs) for the Treatment of Perianal Fistulising Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period up to 104 Weeks

Trial Profile

A Phase III, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess Efficacy and Safety of Expanded Allogeneic Adipose-derived Stem Cells (eASCs) for the Treatment of Perianal Fistulising Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period up to 104 Weeks

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs CX 601 (Primary)
  • Indications Crohn's disease; Rectal fistula
  • Focus Registrational; Therapeutic Use
  • Acronyms ADMIRE; ADMIRE-CD
  • Sponsors TiGenix
  • Most Recent Events

    • 20 Jun 2017 According to a Takeda media release, the Swissmedic has accepted for review the file on Cx601 for the treatment of complex perianal fistulas in Crohn's disease patients. The Swissmedic filing submission included 24- and 52-week data from the trial.
    • 31 May 2017 According to a TiGenix NV media release, the company will submit responses to the CX-601 Marketing Authorization Application Day 180 List of Outstanding Issues (LoOI) during August 2017.
    • 04 May 2017 According to a TiGenix media release, 52-week positive results from this trial will be presented at the 2017 Digestive Disease Week (DDW) annual meeting.
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