Completed

FISPACMulticentre,Randomized,Comparative,Add-on,Into Two Parallel Groups Clinical Trial to Evaluate Efficacy and Safety of Autologous Mesenchymal Stem Cells Derived From Expanded Adipose Tissue (ASC), for Treatment of Complex Perianal Fistulizing Disease in Patients Without IBD.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

◦Drug: ASCs. + fibrin glue

+ fibrin glue

Drug
Who is being recruted

Digestive System Diseases+7

+ Fistula

+ Gastrointestinal Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Last updated: April 19, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

Study of efficacy of adipose derived mesenchimals stem cells and surgery to treat complex perianal fistula

Principal SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Last updated: April 19, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesFistulaGastrointestinal DiseasesIntestinal DiseasesIntestinal FistulaRectal DiseasesPathological Conditions, Signs and SymptomsDigestive System FistulaPathological Conditions, AnatomicalRectal Fistula

Criteria

Inclusion Criteria: Signature of informed consent. Complex perianal fistula cryptoglandular. Understood as a fistula in which at least one of the following circumstances is present: some degree of fecal incontinence associated extrasphinterics fistulas, fistulas supraresfinterianas high transsphincteric fistulas. Patients of both genders, with more that 18 years. Good overall health, according to data from the clinical history and physical examination. Exclusion Criteria: Patient diagnosed with inflammatory bowel disease. Subjects with abscess, except if a complete cleaning of the drainage area of collections is performed and the absence of abscess and other collections larger than 2 cm in maximum diameter before treatment is started is confirmed. History of alcohol or substance abuse in the 6 months prior to inclusion. Malignancy, except in the case of basal cell carcinoma or squamous cell skin or a history of malignancy, unless they have been found in remission during the previous 5 years. medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study. Subjects with congenital or acquired immunodeficiencies. Treponema, Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion. Major surgery or severe trauma of the subject in the previous semester. Pregnant or lactating women. Adult women of childbearing potential not using effective contraception during the trial. Administration of any investigational drug at present to three months prior to enrollment for this trial.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intervention: drug: ASC + fibrin glue Experimental: ASCs+fibrin glue: Subjects will be treated with a dose of 100 million ASCs plus fibrin glue plus a deep curettage and closure of the internal orifice and evaluated after 16 weeks. If needed a second dose of 100 million ASCs plus fibrin glue will be applied then.

Group II

Active Comparator
Intervention: fibrin glue Fibrin glue: Subjects will be treated with a dose fibrin glue plus a deep curettage and closure of the internal orifice, and evaluated after 16 weeks. If needed a second dose of fibrin glue will be applied then.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Hospital Clínico Lozano Blesa

Zaragoza, SpainOpen Hospital Clínico Lozano Blesa in Google Maps

Hospital Clínico Universitario

Salamanca, Spain

Hospital General Universitario

Valencia, Spain

Hospital Universitario La Paz

Madrid, Spain
Completed5 Study Centers