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.
◦Drug: ASCs. + fibrin glue
+ fibrin glue
Digestive System Diseases+7
+ Fistula
+ Gastrointestinal Diseases
Treatment Study
Summary
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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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 Universitario
Salamanca, SpainHospital General Universitario
Valencia, SpainHospital Universitario La Paz
Madrid, Spain