At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 80 target
Drug / intervention
◦Drug: ASCs. + fibrin glue +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicentre,Randomized,Comparative,Add-on,Into Two Parallel Groups Clinical Trial to Evaluate Efficacy and Safety of Autologous Mesenchymal Stem Cells Derived From Expanded Adipose Tissue (ASC), for Treatment of Complex Perianal Fistulizing Disease in Patients Without IBD.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz·interventional·Posted Mar 4, 2013·Updated Apr 19, 2018
In Brief
A Phase 3 clinical trial evaluating ◦Drug: ASCs. + fibrin glue and fibrin glue for Anal Fistula. Completed, enrolled 80 participants across 5 sites.
Detailed Summary
Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal Fistula
CountriesSpain
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedMar 2013
Primary CompletionOct 2017
TodayJul 2026
First PostedMar 4, 2013
Enrollment StartFeb 1, 2013
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.3 years ago
Interventions
◦Drug: ASCs. + fibrin gluedrug
Experimental group
fibrin gluedrug
•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive