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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2019

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At a glance

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

    • 12 Apr 2018 According to a TiGenix media release, 52 week results were presented at the Digestive Disease Week (DDW) annual meeting (May 2017).
    • 23 Mar 2018 According to a TiGenix media release, European Commission (EC) has approved Alofisel (darvadstrocel) to treat complex perianal fistulas in Crohn's disease in Europe.
    • 15 Jan 2018 According to a TiGenix media release, data were published in a Gastroenterology.
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