Experimental study in humans to evaluate the efficacy and safety of blood products rich in proteins for the treatment of anal fistulas in Crohn's patients without subsidiary drug treatment.

• Conditions: Perianal fistulas in Crohn's Disease Patients; MedDRA version: 14.1Level: PTClassification code 10002156Term: Anal fistulaSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2011-006127-38-ES
• Lead Sponsor: Fundación FISEVI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-15
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>;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 <br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Ratio of complex perianal fistula closure in Crohn's disease patients, after 24 and 48 weeks of follow-up.<br>2. Number of draining fistulas after two consecutive visits at weeks 22, 24 and 46, 48.<br>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.