Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

Study Overview
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Brief Summary
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Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

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

Official Title
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Multicentre,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.

Conditions
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Anal Fistula

Intervention / Treatment
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* Drug: ◦Drug: ASCs. + fibrin glue
* Drug: fibrin glue


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC + fibrin glue<br>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. | Drug: ◦Drug: ASCs. + fibrin glue<br>* Experimental group<br>* Other names: Experimental Drug: ASCs + fibrin glue;|
| Active Comparator: Fibrin glue<br>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. | Drug: fibrin glue<br>* •Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/efficacy | Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections>2 cm directly related to the fistula tract treated, as measured by MRI (healing) [ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose ] | 2014, march | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/efficacy | Clinical complexity of fistula (complexity of fistula score) • Safety: Cumulative incidence of adverse effects. • Quality of life (SF-36 score) • Degree of anal incontinence (Wexner incontinence score) [ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose ] | 2015, march | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phase III, Adipose derived stem cells, Anal fistula, Cell therapy, Stem cell therapy