Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula

A Phase II Clinical Trial to Study the Feasibility and Safety of Stromal Vascular Derived From Adipose Tissue for the Treatment of Recto-vaginal Fistula

The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.

SF-12 Test

Inclusion Criteria:

• Signed informed consent
• Recto-vaginal fistula
• Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
• Crohn's disease diagnosed at least 3 months before accepting the clinical criteria

Exclusion Criteria:

• Presence of severe proctitis or dominant active luminal disease requiring immediately therapy
• Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
• Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
• Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
• Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
• Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
• Patients with congenital or acquired immunodeficiencies. HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) or treponema infection, whether active or latent
• Patients who have suffering major surgery or severe trauma in the prior 6 months
• Pregnant or breastfeeding women
• Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.
• Crohns Disease Activity Index (CDAI) Index above 200