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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

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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

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

Latest Information Update: 12 Feb 2025

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At a glance

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

    • Most Recent Events

    • 13 Jan 2025 According to a Takeda media release, company is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel).
    • 15 May 2024 This trial has been completed in Italy, according to European Clinical Trials Database record.
    • 12 May 2024 This trial has been completed in Spain, according to the European Clinical Trials Database record.

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