Experimental study in humans to evaluate the efficacy and safety of bloodproducts rich in proteins for the treatment of anal fistulas in Crohn'spatients

• Conditions: Perianal fistulas in Crohn's Disease Patients; MedDRA version: 14.1Level: LLTClassification code 10068659Term: Perianal 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: EUCTR2011-004820-37-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
Timepoint(s) of evaluation of this end point: Weeks 0, 2, 12, 22, 24, 36, 46 and 48.;Main Objective: Main objective: To evaluate the safety and feasibility of intralesional<br>platelet-rich plasma and fibrin clot from autologous origin, processed with PRGF-System tecnology (BTI), for the treatment of perianal fistulas in Crohn's disease.;Secondary Objective: Secondary objectives: To evaluate the efficacy in terms of ratio of<br>complex perianal fistula closure, decrease in the number of draining<br>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<br>months post-treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Ratio of complex perianal fistula closure in Crohn's disease patients,<br>after 24 and 48 weeks of follow-up.<br>2. Number of draining fistulas after two consecutive visits at weeks 22,<br>24 and 46, 48.<br>3. Percentage of subjects with healed fistula (measured by MRI) after 12<br>and 24 weeks of follow-up.;Timepoint(s) of evaluation of this end point: Weeks 0, 2, 12, 22, 24, 36, 46 and 48.