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

Sponsor
Instituto de Investigación Hospital Universitario La Paz (Other)
Overall Status
Unknown status
CT.gov ID
NCT01584713
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
24
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Adipose-derived stem cells without expanded
 Phase 1/Phase 2

Detailed Description

SF-12 Test

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Clinical Trial to Study the Feasibility and Safety of Stromal Vascular Derived From Adipose Tissue for the Treatment of Enterocutaneous Fistula
Study Start Date :
Dec 1, 2011
Anticipated Primary Completion Date :
Jul 1, 2012
Anticipated Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adipose derived Stem Cells

Drug: Adipose-derived stem cells without expanded
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
Other Names:
  • Non applicable

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. quality of life test [16 week]

      Test SF 12 of quality of life

    2. First efficacy data [16 weeks]

      Fistula closure by radiology

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario La Paz Madrid Spain 28046

    Sponsors and Collaborators

    • Instituto de Investigación Hospital Universitario La Paz

    Investigators

    • Principal Investigator: Mariano Garcia-Arranz, Doctor, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Instituto de Investigación Hospital Universitario La Paz
    ClinicalTrials.gov Identifier:
    NCT01584713
    Other Study ID Numbers:
    • EC10-345
    • 2010-024308-82
    First Posted:
    Apr 25, 2012
    Last Update Posted:
    Apr 25, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Instituto de Investigación Hospital Universitario La Paz
    Enterocutaneous fistula
    Adipose Derived Stem Cells
    Additional relevant MeSH terms:
    Intestinal Fistula
    Fistula

    Study Results

    No Results Posted as of Apr 25, 2012