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
- Registration Number
- NCT01020825
- Lead Sponsor
- Tigenix S.A.U.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- At least 1 dose of the treatment assigned in the FATT-1 trial
- Informed consent
- Other experimental drugs other than Cx401 during the follow-up period
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fibrin glue Fibrin glue Patients randomized to the control treatment (application of fibrin glue) in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\] ASCs + Fibrin Glue ASCs Patients randomized to the control treatment (application of fibrin glue) + intralesional injection of ASCs in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\] ASCs ASCs Patients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\]
- Primary Outcome Measures
Name Time Method Cumulative incidence of adverse events (clinical or laboratory) attributed to the study therapy in the preceding FATT-1 randomized trial (CX401 or fibrin glue) 6 months (since last visit in FATT-1 trial)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (15)
Hospital General Univeritario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Nuestra Señora de Valme
🇪🇸Seville, Spain
Hospital de Sagunto
🇪🇸Sagunto, Valencia, Spain
Hospital ClÃnico San Carlos
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
ClÃnica Universitaria Navarra
🇪🇸Pamplona, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Doctor Josep Trueta
🇪🇸Girona, Spain
Hospital Mutua de Terrasa
🇪🇸Terrasa, Barcelona, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital de Fuenlabrada
🇪🇸Fuenlabrada, Madrid, Spain
Hospital Universitari Joan XXIII
🇪🇸Tarragona, Spain
Hospital ClÃnico Universitario "Lozano Blesa"
🇪🇸Zaragoza, Spain