Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

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

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.