Clinical Trial: Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Phase II Clinical Trial to Study the Feasibility and Safety of Stromal Vascular Derived From Adipose Tissue for the Treatment of Recto-vaginal Fistula
Brief Summary: The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.
Detailed Summary: SF-12 Test
Sponsor: Instituto de Investigación Hospital Universitario La Paz
Current Primary Outcome: Safety of treatment of treated recto-vaginal fistulae. Percentage of treated enterocutaneous fistulae and percentage of subjects with closed fistulae [ Time Frame: 16 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ]Test SF-12 of quality of life
- Adverse events [ Time Frame: 1, 4, 12, 24 weeks ]Control by investigation team of CRD (data collections)
Original Secondary Outcome: Same as current
Information By: Instituto de Investigación Hospital Universitario La Paz
Dates:
Date Received: February 26, 2012
Date Started: December 2011
Date Completion: December 2013
Last Updated: March 5, 2012
Last Verified: March 2012