Anal fistula is defined as an abnormal communication between the anal canal and the perianal skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas. This study will test the safety and efficacy of ASCs (adipose stem cells) in the treatment of patients without Crohn´s disease.
Perianal fistula accounts for 10% to 30% of coloproctological surgical procedures. Currently accepted conventional treatment is surgery intended to treat the tracts using different technical options. This surgery usually has a highly bothersome postoperative period and may involve two major complications: anal incontinence and recurrence. The biological properties of stem cells derived from adult tissues make them adequate candidates for the treatment of diseases in which tissues are damaged or the healing process is altered. This study will compare the efficacy of ASCs versus ASCs plus Fibrin adhesive versus Fibrin adhesive alone for closure of complex perianal fistulas not associated to Inflammatory Bowel Disease. Fistula closure is defined as absence of suppuration and re-epithelization of the external opening in the clinical evaluation and absence of collections \>2 cm directly related to the fistula tract treated, as measured by MRI
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
214
Experimental: ASCs: Subjects will be treated with a dose of 20 million ASCs and evaluated after 12 weeks. If needed a second dose of 40 million ASCs will be applied then. Experimental: ASCs+fibrin glue: Subjects will be treated with a dose of 20 million ASCs plus fibrin glue and evaluated after 12 weeks. If needed a second dose of 40 million ASCs plus fibrin glue will be applied then.
Experimental: Fibrin glue: Subjects will be treated with a dose fibrin glue and evaluated after 12 weeks. If needed a second dose of fibrin glue will be applied then.
Universitary Clinical Surgery
Mannheim, Germany
Lozano Blesa Clinical Hospital
Zaragoza, Aragon, Spain
Virgen Del Camino Hospital
Pamplona, Navarre, Spain
Mutua de Terrasa Hospital
Tarrasa, Tarragona, Spain
Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections>2 cm directly related to the fistula tract treated, as measured by MRI (healing)
Time frame: weeks 1, 4, 12 and 24. Week 26 in patients with a second dose
• Clinical complexity of fistula (complexity of fistula score) • Safety: Cumulative incidence of adverse effects. • Quality of life (SF-36 score) • Degree of anal incontinence (Wexner incontinence score)
Time frame: weeks 1, 4, 12 and 24. Week 26 in patients with a second dose
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Gregorio Marañon University Hospital
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San Carlos Clinical Hospital
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12 De Octubre University Hospital
Madrid, Spain
La Paz University Hospital
Madrid, Spain
Universitary General Hospital
Valencia, Spain
John Radcliff Hospital
Oxford, Oxfordshire, United Kingdom