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.

Trial Profile

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.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs CX 601 (Primary)
  • Indications Rectal fistula
  • Focus Registrational; Therapeutic Use
  • Acronyms ADMIRE-CD II
  • Sponsors TiGenix
  • Most Recent Events

    • 29 Jun 2017 According to a TiGenix media release, the company anticipates starting recruitment for the trial in North American centers in H1 2018.
    • 29 Jun 2017 Status changed from planning to recruiting, according to a TiGenix media release.
    • 06 Mar 2017 According to a TiGenix media release, the FDA has agreed that the BLA could be filed based on the efficacy and safety follow-up of patients assessed at week 24, instead of week 52. Furthermore, the FDA has agreed to accept fewer patients than originally planned in the study, and has endorsed a broader target population that will ultimately facilitate the recruitment process.
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