Clinical Trial: Stromal Vascular Fraction (SVF) for Treatment of Enterocutaneous Fistula (HULPUTC)

Study Status: Not yet recruiting
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 Enterocutaneous Fistula

Brief Summary: The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of enterocutaneous fistula.

Detailed Summary: SF-12 Test
Sponsor: Instituto de Investigación Hospital Universitario La Paz

Current Primary Outcome: Safety of treatment of treated enterocutaneous fistulae. Percentage of treated subjects with closed fistulae [ Time Frame: 16 weeks ]

Safety by analyzing the number of adverse effects associated with experimental treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • quality of life test [ Time Frame: 16 week ]
    Test SF 12 of quality of life
  • First efficacy data [ Time Frame: 16 weeks ]
    Fistula closure by radiology


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: April 23, 2012
Last Verified: April 2012