NCT00999115

Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)

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 Crohn´s Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectovaginal Fistula
• Crohn Disease

Interventions

Type	Name	Description
DRUG	Expanded allogenic adipose-derived adult stem cells	Administration will be preceded by localization and closure of the internal opening. Cell treatment injection will be performed following Major Ambulatory Surgery standards. Patients will receive an intralesional dose of 20 million cells at baseline. 50% of the cell suspension will be placed into fistula walls of the internal opening, with the remaining 50% being injected across the wall tracts of the target fistula. Patients without healing (complete fistula closure)at week 12 will receive a second dose of 40 million cells, using the same treatment approach.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2009-10-21
• Last updated: 2012-01-26

Locations

1 site across 1 country: Spain