Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2008-003140-10 | Other Identifier | EMEA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASCs | Patients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410] |
| |
| 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 | 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] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASCs | Drug | Intralesional injection of adult-stem-cells at a dose of 20 and 40 million. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients that received at least one treatment dose in study Cx401/FATT1
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Damián García-Olmo, MD | General Surgery Department, Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Mutua de Terrasa | Terrassa | Barcelona | 08221 | Spain | ||
| Hospital Universitario Marqués de Valdecilla |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12756590 | Background | Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20. | |
| 15933795 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fibrin glue | Drug | After curettage, the fistulous tract was sealed with fibrin glue. |
|
| ASCs | Drug | Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue. |
|
|
| Santander |
| Cantabria |
| 39008 |
| Spain |
| Hospital de Fuenlabrada | Fuenlabrada | Madrid | 28942 | Spain |
| Hospital de Sagunto | Sagunto | Valencia | 46520 | Spain |
| Hospital Doctor Josep Trueta | Girona | 17007 | Spain |
| Hospital Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Clínica Universitaria Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Nuestra Señora de Valme | Seville | 41014 | Spain |
| Hospital Universitari Joan XXIII | Tarragona | 17300 | Spain |
| Hospital General Univeritario de Valencia | Valencia | 46014 | Spain |
| Hospital Clínico Universitario "Lozano Blesa" | Zaragoza | 50009 | Spain |
| Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. doi: 10.1007/s10350-005-0052-6. |
| 18696086 | Background | Garcia-Olmo D, Herreros D, Pascual M, Pascual I, De-La-Quintana P, Trebol J, Garcia-Arranz M. Treatment of enterocutaneous fistula in Crohn's Disease with adipose-derived stem cells: a comparison of protocols with and without cell expansion. Int J Colorectal Dis. 2009 Jan;24(1):27-30. doi: 10.1007/s00384-008-0559-0. Epub 2008 Aug 12. |
| 18694359 | Background | Garcia-Olmo D, Garcia-Arranz M, Herreros D. Expanded adipose-derived stem cells for the treatment of complex perianal fistula including Crohn's disease. Expert Opin Biol Ther. 2008 Sep;8(9):1417-23. doi: 10.1517/14712598.8.9.1417. |
| 22706128 | Derived | Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a. |
| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided