Stromal Vascular Fraction (SVF) for Treatment of Enterocutaneous Fistula (HULPUTC)

Phase 1

• Conditions: Enterocutaneous Fistula
• Interventions: Drug: Adipose-derived stem cells without expanded

• Registration Number: NCT01584713
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

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

Detailed Description

SF-12 Test

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-26
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-23
• Last Update Submitted: 2012-04-23
• Study First Posted: 2012-04-25
• Last Update Posted: 2012-04-25
• Primary Completion: 2012-07
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Signed informed consent
• Enterocutaneous 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

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, HBV, 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adipose derived Stem Cells	Adipose-derived stem cells without expanded	-

Primary Outcome Measures

Name	Time	Method
Safety of treatment of treated enterocutaneous fistulae. Percentage of treated subjects with closed fistulae	16 weeks	Safety by analyzing the number of adverse effects associated with experimental treatment.

Secondary Outcome Measures

Name	Time	Method
quality of life test	16 week	Test SF 12 of quality of life
First efficacy data	16 weeks	Fistula closure by radiology

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain