Perianal fistulas in Crohn's Disease Patients MedDRA version: 14.1 Level: PT Classification code 10002156 Term: Anal fistula System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Fundación FISEVI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 or over / Confirmed diagnosis of Crohn's disease a year before the inclusion date / Presence of perianal fistula / Identifiable internal orifice / Demonstration activity of the fistulizing perianal pathology based on clinical (including PDAI) and radiological (pelvic MRI and endoanal ultrasound) criteria / Presence of 3 or less fistulous tracts / No inflamatory activity in the rectum or proctitis (confirmed by colonoscopy) / Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Superficial fistulas whose treatment of choice is fistulotomy / Presence of more than 3 fistulous tracts / Rectourethral and rectovaginal fistulas / Endoanal abscesses larger than 2 cm detected by physical examination or imaging (pelvic MRI endoanal ultrasound) / Current anorectal tumors / Clinically significant anal fissures or stenosis which prevent the rectoscopy or similar procedures / Impossibility of performing MRI for any reason (prosthesis, contrast allergy, claustrophobia ...) / Impossibility of performing endoanal ultrasound for any reason / Clinically inactive fistulizing disease (including PDAI) / Pregnant women or women in the first 6 months post-partum / Chemotherapy performed in the 6 months prior to study inclusion/ Bleeding diathesis or concurrent anticoagulant therapy / Prior radiation with evidence of radiation injury in the treatment area / Participation in any clinical trial during the 3 months prior to the screening visit / Other serious conditions or bio-psycho-social factors that may predict lack of compliance with study procedures / Major surgery or serious trauma of the subject in the previous semester / Congenital or acquired immunodeficiencies / Presence of surgical threads, unless they can be removed before starting treatment / Severe proctitis (striking friability, spontaneous bleeding, multiple erosions, deep ulcers), judging by the sigmoidoscopy / Malignancy in remission for less than a years before study inclusion, with the exception of basal cell carcinoma (BCC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective: To evaluate the safety and feasibility of intralesional platelet-rich plasma and fibrin clot from autologous origin, processed with PRGF-System tecnology, for the treatment of perianal fistulas in Crohn's disease. ;Secondary Objective: Secondary objectives: To evaluate the efficacy in terms of ratio of complex perianal fistula closure, decrease in the number of draining fistulas after two consecutive visits, and percentage of subjects with healed fistula (measured by MRI).;Primary end point(s): Incidence of IMP-related adverse events during a follow-up period of 12 months post-treatment.;Timepoint(s) of evaluation of this end point: Weeks 0, 2, 12, 22, 24, 36, 46 and 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Ratio of complex perianal fistula closure in Crohn's disease patients, after 24 and 48 weeks of follow-up. 2. Number of draining fistulas after two consecutive visits at weeks 22, 24 and 46, 48. 3. Percentage of subjects with healed fistula (measured by MRI) after 12 and 24 weeks of follow-up.;Timepoint(s) of evaluation of this end point: Weeks 0, 2, 12, 22, 24, 36, 46 and 48. | — |
Countries
Spain
Contacts
Public ContactClara M. Rosso Fernández
UCICEC-Virgen del Rocío
Outcome results
None listed