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: 05 Oct 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

    • 05 Oct 2017 According to a TiGenix media release, 52-week results from the study has been selected for an oral presentation at the World Congress of Gastroenterology at the American Congress of Gastroenterology 2017 Annual Scientific Meeting (WCOG/ACG).
    • 02 Oct 2017 According to a TiGenix media release, data from this trial will be discussed in an event for analysts and investors 2017.
    • 19 Sep 2017 According to a TiGenix media release, the company has submitted responses to the Cx601 Marketing Authorization (MA) Application Day 180 List of Outstanding Issues from the Committee for Medicinal Products for Human Use (CHMP) in September 2017. The company expects a CHMP opinion in 2017.
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