Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery
Study of efficacy of adipose derived mesenchimals stem cells and surgery to treat complex perianal fistula
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Experimental group
•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive
Hospital Clínico Lozano Blesa
Zaragoza, Aragon, Spain
Hospital Clínico Universitario
Salamanca, Castille and León, Spain
Hospital General Universitario
Valencia, Valencia, Spain
Hospital Universitario La Paz
Madrid, Spain
Safety/efficacy
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) \[ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose \]
Time frame: 2014, march
Safety/efficacy
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) \[ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose \]
Time frame: 2015, march
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Clínica Universitaria de Navarra
Pamplona, Spain