Phase-III Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicentre Study to Assess Efficacy and Safety of Cx601, Allogeneic Expanded Adipose-derived Stem Cells for Complex Perianal Fistula(s) in Crohn's Disease.ADMIRE-CD-II
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 24 Oct 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.