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 (LTE)

TigenixU

Status: Completed

Conditions: Complex Perianal Fistula

Treatments: Drug: ASCs; Drug: Fibrin glue

Study type: Observational

Funder types: Industry

Identifiers

NCT01020825

CX401-0303

EudraCT: 2008-003140-10 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

148 participants in 3 patient groups

ASCs

Description:

Patients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\]

Treatment:

Drug: ASCs

Drug: ASCs

Fibrin glue

Description:

Patients randomized to the control treatment (application of fibrin glue) in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\]

Treatment:

Drug: Fibrin glue

ASCs + Fibrin Glue

Description:

Patients randomized to the control treatment (application of fibrin glue) + intralesional injection of ASCs in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\]

Treatment:

Drug: ASCs

Drug: ASCs