Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

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.

Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

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

Inclusion Criteria:

1. Signature of informed consent.

2. 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.

3. Patients of both genders, with more that 18 years.

4. Good overall health, according to data from the clinical history and physical examination.

Exclusion Criteria:

1. Patient diagnosed with inflammatory bowel disease.
2. 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.
3. History of alcohol or substance abuse in the 6 months prior to inclusion.
4. 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.
5. medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study.
6. Subjects with congenital or acquired immunodeficiencies. Treponema, Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion.
7. Major surgery or severe trauma of the subject in the previous semester.
8. Pregnant or lactating women.
9. Adult women of childbearing potential not using effective contraception during the trial.
10. Administration of any investigational drug at present to three months prior to enrollment for this trial.