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
NCT ID: NCT01020825
Last Updated: 2019-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
148 participants
OBSERVATIONAL
2008-09-30
2010-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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ASCs
Patients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\]
ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
Fibrin glue
Patients randomized to the control treatment (application of fibrin glue) in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\]
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 \[ClinicalTrials.gov identifier: NTC00475410\]
ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.
Interventions
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ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
Fibrin glue
After curettage, the fistulous tract was sealed with fibrin glue.
ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Tigenix S.A.U.
INDUSTRY
Responsible Party
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Principal Investigators
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Damián García-Olmo, MD
Role: PRINCIPAL_INVESTIGATOR
General Surgery Department, Hospital Universitario La Paz
Locations
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Hospital Mutua de Terrasa
Terrassa, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Doctor Josep Trueta
Girona, , Spain
Hospital Gregorio Marañón
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Clínica Universitaria Navarra
Pamplona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Nuestra Señora de Valme
Seville, , Spain
Hospital Universitari Joan XXIII
Tarragona, , Spain
Hospital General Univeritario de Valencia
Valencia, , Spain
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, , Spain
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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EudraCT: 2008-003140-10
Identifier Type: OTHER
Identifier Source: secondary_id
CX401-0303
Identifier Type: -
Identifier Source: org_study_id
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