LTE: 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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ASCs Patients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410] |
Drug: ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
Other Names:
|
| Fibrin glue 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] |
Drug: ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Mutua de Terrasa | Terrasa | Barcelona | Spain | 08221 |
| 2 | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | Spain | 39008 |
| 3 | Hospital de Fuenlabrada | Fuenlabrada | Madrid | Spain | 28942 |
| 4 | Hospital de Sagunto | Sagunto | Valencia | Spain | 46520 |
| 5 | Hospital Doctor Josep Trueta | Girona | Spain | 17007 | |
| 6 | Hospital Gregorio Marañón | Madrid | Spain | 28007 | |
| 7 | Hospital Clínico San Carlos | Madrid | Spain | 28040 | |
| 8 | Hospital 12 de Octubre | Madrid | Spain | 28041 | |
| 9 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
| 10 | Clínica Universitaria Navarra | Pamplona | Spain | 31008 | |
| 11 | Hospital Universitario de Salamanca | Salamanca | Spain | 37007 | |
| 12 | Hospital Universitario Nuestra Señora de Valme | Seville | Spain | 41014 | |
| 13 | Hospital Universitari Joan XXIII | Tarragona | Spain | 17300 | |
| 14 | Hospital General Univeritario de Valencia | Valencia | Spain | 46014 | |
| 15 | Hospital Clínico Universitario "Lozano Blesa" | Zaragoza | Spain | 50009 |
Sponsors and Collaborators
- Tigenix S.A.U.
Investigators
- Principal Investigator: Damián García-Olmo, MD, General Surgery Department, Hospital Universitario La Paz
Study Documents (Full-Text)
None provided.More Information
Publications
- García-Olmo D, García-Arranz M, García LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, García-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. Epub 2003 May 20.
- García-Olmo D, García-Arranz M, Herreros D, Pascual I, Peiro C, Rodríguez-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.
- 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 . Review.
- 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.
- CX401-0303
- EudraCT: 2008-003140-10