1 Study Matches
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. ADMIRE-CD II study.
This study is for patients with Crohn's disease which involves an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). The purpose of this study is to find out: 1) How well the study drug works at a single dose compared to a placebo; 2) how safe and tolerable the study drug is in patients with fistulizing CD.
18 year(s) or older
Inclusion Criteria:Diagnosis of Crohn's Disease for at least 6 months
Presence of complex perianal fistulas
Clinically controlled, non active or mildly active CD during the last 6 months
Patients whose perianal fistulas were previously treated and have shown an inadequate response
Exclusion Criteria:Any major surgery of the GI tract within past 6 months
Patients without prior specific treatment for perianal complex fistulas
Patients with diverting stomas
Patients with active, uncontrolled infection requiring IV antibiotics
Patients with allergies or hypersensitivity to penicillin or aminoglycosides, local anesthetics or MRI contrast
Infectious Diseases & Immune System, Digestive Systems & Liver Disease