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)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Prospective Study for the Assessment of the Long-term Safety and Efficacy of Cx401 in Patients Taking Part in the FATT-1 Trial|
- 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) ] [ Designated as safety issue: Yes ]
- 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) ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Patients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410]
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
Patients randomized to the control treatment (application of fibrin glue) in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410]
Drug: Fibrin glue
After curettage, the fistulous tract was sealed with 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]
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020825
|Hospital Mutua de Terrasa|
|Terrasa, Barcelona, Spain, 08221|
|Hospital Universitario Marqués de Valdecilla|
|Santander, Cantabria, Spain, 39008|
|Hospital de Fuenlabrada|
|Fuenlabrada, Madrid, Spain, 28942|
|Hospital de Sagunto|
|Sagunto, Valencia, Spain, 46520|
|Hospital Doctor Josep Trueta|
|Girona, Spain, 17007|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|Hospital Gregorio Marañón|
|Madrid, Spain, 28007|
|Hospital 12 de Octubre|
|Madrid, Spain, 28041|
|Clínica Universitaria Navarra|
|Pamplona, Spain, 31008|
|Hospital Universitario de Salamanca|
|Salamanca, Spain, 37007|
|Hospital Universitario Nuestra Señora de Valme|
|Seville, Spain, 41014|
|Hospital Universitari Joan XXIII|
|Tarragona, Spain, 17300|
|Hospital General Univeritario de Valencia|
|Valencia, Spain, 46014|
|Hospital Clínico Universitario "Lozano Blesa"|
|Zaragoza, Spain, 50009|
|Principal Investigator:||Damián García-Olmo, MD||General Surgery Department, Hospital Universitario La Paz|