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 ]

Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound


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