Crohn's Admirell Study
The purpose of this study is to evaluate the safety and efficacy of a study drug called Cx601 in patients with complex perianal fistula(s) and moderate to severe Crohn’s disease.
About
Protocol Description
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.
Eligibility Criteria
Inclusion Criteria
- Must be at least ≥18 and ≤75 years of age
- Have had a diagnosis of Crohn's Disease established at least 6 months prior to enrollment confirmed by clinical, endoscopic, and histological criteria
- Presence of complex perianal fistula(s)
- Able to provide informed consent
Exclusion Criteria
- You have concomitant rectovaginal or rectovesical fistula(s)
- You have severe rectal and/or anal stenosis and/or severe proctitis
- You have diverting stomas
- You have an active, uncontrolled infection requiring parenteral antibiotics
- You have suspected or documented infectious enterocolitis within 2 weeks prior to screening visit
Primary Investigator
Assistant Professor of Medicine & Associate Professor at Virginia Tech Carilion School of Medicine
Contact Information
Nicholas (Nick) Bilbro, M.P.H., C.H.E.S.
Clinical Research Coordinator
