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

Overview

Phase: Phase 1
Intervention: Adipose-derived stem cells without expanded
Conditions: Recto-vaginal Fistula
Sponsor: Instituto de Investigación Hospital Universitario La Paz
Enrollment: 10
Locations: 1
Primary Endpoint: Safety of treatment of treated recto-vaginal fistulae. Percentage of treated enterocutaneous fistulae and percentage of subjects with closed fistulae
Last Updated: 14 years ago

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

SF-12 Test

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

December 2013

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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.