Fistula perianal compleja en la enfermedad perianal de Crohn Complex perianal fistula in perianal Crohn´s disease MedDRA version: 9 Level: LLT Classification code 10002156 Term: Anal fistula
Conditions
Interventions
Product Name: ASCs: Adipose derived Stem Cells
Product Code: Cx401
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: ASCs
CAS Number: No procede
Current Sponsor code: No procede
Other
Sponsors
CELLERIX S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for this study, patients should meet ALL the following criteria: 1. Received at least one dose of the treatment assigned in the FATT2 trial. 2. Patient should give his/her written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible for this study, patients should meet NONE of the following criteria: 1. Receive clinical investigational drugs other than Cx401 during the follow-up period. 2. Treatment with Infliximab or any other anti-TNF treatment throughout the study (only applicable to patients allocated to the placebo group during the FATT2 core study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the long-term safety of Cx401 in patients with complex perianal fistulas in Crohn?s disease.;Secondary Objective: To assess the state of closure of the fistula (MRI) at 24 weeks of follow-up in all patients of the extension study, and at 12 weeks of follow-up in those patients who received placebo in the FATT2 core study.;Primary end point(s): All clinical and laboratory adverse events will be recorded during the follow-up contacts: at baseline and 24 weeks of the extension period in patients treated with Cx401 in the FATT2 core study; and at baseline, implant, 1, 12, 13 and 24 weeks in patients treated with placebo in the FATT2 core study. The primary variable will be the cumulative incidence of adverse events attributed to the study therapy (Cx401). | — |
Countries
Spain
Outcome results
None listed