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

N/ACompletedNCT01020825

Tigenix S.A.U.148 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

148

Conditions

Complex Perianal Fistula

Interventions

ASCsDRUG

Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.

Fibrin glueDRUG

After curettage, the fistulous tract was sealed with fibrin glue.

ASCsDRUG

Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 1 dose of the treatment assigned in the FATT-1 trial * Informed consent Exclusion Criteria: * Other experimental drugs other than Cx401 during the follow-up period

Locations (15)

Hospital Mutua de Terrasa

Terrassa, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital de Fuenlabrada

Fuenlabrada, Madrid, Spain

Outcomes

Primary Outcomes

Cumulative incidence of adverse events (clinical or laboratory) attributed to the study therapy in the preceding FATT-1 randomized trial (CX401 or fibrin glue)

Time frame: 6 months (since last visit in FATT-1 trial)

Secondary Outcomes

Closure of the fistula (defined as suppuration through the external opening of the fistula spontaneously and on pressure, complete re-epithelization of the external opening in the clinical evaluation and absence of collections >2 cm in MRI)

Time frame: 6 months (since last visit of FATT-1 trial)

Data from ClinicalTrials.gov

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