Phase-III Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicentre Study to Assess Efficacy and Safety of Cx601, Allogeneic Expanded Adipose-derived Stem Cells for Complex Perianal Fistula(s) in Crohn's Disease.ADMIRE-CD-II

Trial Profile

Phase-III Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicentre Study to Assess Efficacy and Safety of Cx601, Allogeneic Expanded Adipose-derived Stem Cells for Complex Perianal Fistula(s) in Crohn's Disease.ADMIRE-CD-II

Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2018

At a glance

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

    • 12 Apr 2018 According to a TiGenix media release, as of March 31, 2018, patients have been recruited into the trial across 37 sites in seven European countries. IND clearance for the start of US recruitment is expected by the end of 2018.
    • 17 Nov 2017 Status changed from not yet recruiting to recruiting.
    • 29 Jun 2017 According to a TiGenix media release, the company anticipates starting recruitment for the trial in North American centers in H1 2018.
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