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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: 12 Feb 2025

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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

  • 13 Dec 2024 According to a Takeda media release, company is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel).
  • 17 Oct 2023 According to a Takeda media release, Alofisel is approved in the European Union, Israel, Switzerland, Serbia, United Kingdom and Japan based on positive data from the ADMIRE-CD study
  • 27 Sep 2021 According to a Takeda media release, the company received approval from the Japan Ministry of Health, Labour and Welfare to manufacture and market Alofisel (darvadstrocel) for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn's disease (CD), based on data from Darvadstrocel-3002 and ADMIRE-CD trial.

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