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

This study is currently recruiting participants.
Verified March 2012 by Instituto de Investigación Hospital Universitario La Paz
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT01548092
First received: February 26, 2012
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Recto-vaginal Fistula
Drug: Adipose-derived stem cells without expanded
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Recto-vaginal Fistula

Resource links provided by NLM:


Further study details as provided by Instituto de Investigación Hospital Universitario La Paz:

Primary Outcome Measures:
  • Safety of treatment of treated recto-vaginal fistulae. Percentage of treated enterocutaneous fistulae and percentage of subjects with closed fistulae [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound


Secondary Outcome Measures:
  • Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ] [ Designated as safety issue: No ]
    Test SF-12 of quality of life

  • Adverse events [ Time Frame: 1, 4, 12, 24 weeks ] [ Designated as safety issue: Yes ]
    Control by investigation team of CRD (data collections)


Estimated Enrollment: 10
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous SVF
Intralesional application
Drug: Adipose-derived stem cells without expanded
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
Other Name: Adipose-Derived Mesenchymal Stem Cells

Detailed Description:

SF-12 Test

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548092

Contacts
Contact: Mariano Garcia Arranz +34912071022 mgarciaa.hulp@salud.madrid.org
Contact: Maria Dolores Herreos +34912071022 loles.herreros@gmail.com

Locations
Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28039
Contact: Mariano García Arranz     +34912071022     mgarciaa.hulp@salud.madrid.org    
Principal Investigator: Maria Dolores Herreros            
Sub-Investigator: Damián García Olmo            
Sub-Investigator: Tihomir Hirstov            
Sub-Investigator: Héctor Guadalajara            
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
Principal Investigator: Mariano García Arranz, PhD Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz
  More Information

Publications:

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01548092     History of Changes
Other Study ID Numbers: EC10-343, 2010-024330-35
Study First Received: February 26, 2012
Last Updated: March 5, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Recto-vaginal fistula
Adipose Derived Stem Cells

Additional relevant MeSH terms:
Fistula
Rectovaginal Fistula
Vaginal Fistula
Pathological Conditions, Anatomical
Rectal Fistula
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013