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.
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
- 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.