Clinical Trial: Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn`s Disease (ALOREVA)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in
Brief Summary: The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.
Detailed Summary:
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Current Primary Outcome: Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Quality of life assessment using the SF-36 questionnaire [ Time Frame: 12 weeks ]
- Adverse events [ Time Frame: 1, 4, 8,12, 24, 54 weeks ]
- Clinically relevant variations in laboratory test [ Time Frame: 1, 4 8, 12, 24, 54 weeks ]
- Quality of life assessment using the SF-36 questionnaire [ Time Frame: 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Dates:
Date Received: October 20, 2009
Date Started: September 2009
Date Completion:
Last Updated: January 25, 2012
Last Verified: January 2012
