Clinical Trial TitleStudy to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC) for the treatment of complex perianal fistula(s) in participants with Crohn's disease (CD) (ADMIRE-CD-II).
National Clinical Trial Number:NCT03279081
Clinical Trial Protocol Description:
The purpose of this phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female and between 18 and 75 years of age.
- Have been diagnosed with Crohn's Disease at least 6 months prior to Screening visit.
- Have presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment.
- For patients whose perianal fistulas were previously treated: Have shown an inadequate response or a loss of response while receiving treatments, or have documented intolerance to treatments.
You will be excluded from the study if any of the following criteria apply to you:
- Have concomitant rectovaginal or rectovesical fistula(s).
- Are naïve to prior specific medical treatment for complex perianal fistula(s) including IS or anti-TNFs.
- Have the presence of a perianal collection >2cm in at least two dimensions on the central reading MRI at Screening.
- Have diverting stomas.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.