NCT01020825

Long-term Safety and Efficacy of Adipose-derived Stem Cells to Treat Complex Perianal Fistulas in Patients Participating in the FATT-1 Randomized Controlled Trial

A Prospective Study for the Assessment of the Long-term Safety and Efficacy of Cx401 in Patients Taking Part in the FATT-1 Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 148 (actual)
• Sponsor: Tigenix S.A.U. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this extension is to investigate and confirm the long-term (6 months) safety and efficacy of the preceding FATT-1 trial \[ClinicalTrials.gov identifier: NTC00475410\], which studied patients with perianal fistula treated having received adipose-derived adult stem cell (ASC)and/or fibrin glue.

Detailed description

Complex perianal fistulas are a source of great distress for suffers. Treatment options are limited and surgery is often associated with incontinence and recurrence. The biological properties of stem cells derived from adult tissues make them candidates for the treatment of pathologies requiring tissue regeneration or in diseases where the healing process is altered. This study aims to evaluate the safety and efficacy of patients having participated within a preceding multicenter, placebo-controlled, phase 3 study \[ClinicalTrials.gov identifier: NTC00475410\]. The present extension aims to collect safety and efficacy data for up to 12 month from initial administration. Fistula closure is defined as absence of suppuration through the external orifice with complete re-epithelization of the external orifice and absence of collections \>2cm directly related to the fistula tract treated, as measured by MRI.

Conditions

• Complex Perianal Fistula

Interventions

Type	Name	Description
DRUG	ASCs	Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
DRUG	Fibrin glue	After curettage, the fistulous tract was sealed with fibrin glue.
DRUG	ASCs	Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2009-11-26
• Last updated: 2019-04-12

Locations

15 sites across 1 country: Spain