NCT00115466

Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula

Phase II Clinical Trial, Multicentre, Randomised and Comparative, to Evaluate the Efficacy and Safety of a New Therapy With Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: Cellerix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the non-surgical treatment of complex perianal fistula.

Detailed description

Comparative, multicentre, randomised clinical trial, designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the NON-SURGICAL treatment of complex perianal fistula. The closure/healing of the fistula will be evaluated periodically, and it will be considered completely closed if there is no suppuration from the external orifice and re-epithelialisation can be observed at 8 weeks after the administration of the randomised therapy.

Conditions

• Anal Fistula

Interventions

Type	Name	Description
PROCEDURE	Non-surgical autologous implant of ASCs

Timeline

• Start date: 2004-10-01
• Completion: 2006-07-01
• First posted: 2005-06-23
• Last updated: 2005-06-24

Locations

1 site across 1 country: Spain