A Prospective Study for the Assessment of the Long-term Safety and Efficacy of Cx401 in Patients Taking Part in the FATT-1 Trial
Overview
- Phase
- Not Applicable
- Intervention
- ASCs
- Conditions
- Complex Perianal Fistula
- Sponsor
- Tigenix S.A.U.
- Enrollment
- 148
- Locations
- 15
- Primary Endpoint
- Cumulative incidence of adverse events (clinical or laboratory) attributed to the study therapy in the preceding FATT-1 randomized trial (CX401 or fibrin glue)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
ASCs
Patients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\]
Intervention: ASCs
Fibrin glue
Patients randomized to the control treatment (application of fibrin glue) in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\]
Intervention: Fibrin glue
ASCs + Fibrin Glue
Patients randomized to the control treatment (application of fibrin glue) + intralesional injection of ASCs in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\]
Intervention: ASCs
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)(6 months (since last visit of FATT-1 trial))