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

• Register: EUCTR
• Last refreshed on: 26 June 2012
• Main ID: EUCTR2011-004820-37-ES
• Date of registration: 15/02/2012
• Prospective Registration: Yes
• Primary sponsor: Fundación FISEVI
• Public title: 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
• Scientific title: Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's patients
• Date of first enrolment: 13/06/2012
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004820-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Spain

Contacts

• Name: Clara M. Rosso Fernández
• Affiliation: UCICEC-Hospital Virgen del Rocío

• Name: Clara M. Rosso Fernández
• Affiliation: UCICEC-Hospital Virgen del Rocío

Key inclusion & exclusion 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:
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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Perianal fistulas in Crohn's Disease Patients
MedDRA version: 14.1 Level: LLT Classification code 10068659 Term: Perianal 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

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Intervention(s)

Product Name: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
Pharmaceutical Form: Rectal solution
INN or Proposed INN: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
Other descriptive name: HUMAN PLASMA FOR FRACTIONATION
Concentration unit: % percent
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

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).

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
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.

Primary end point(s): Incidence of IMP-related adverse events during a follow-up period of 12
months post-treatment.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Weeks 0, 2, 12, 22, 24, 36, 46 and 48.

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.

Secondary ID(s)

PRGF/AF/2011

Source(s) of Monetary Support

Consejería de Salud (Junta de Andalucía)