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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Instituto de Investigación Hospital Universitario La Paz.
Recruitment status was  Recruiting
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

February 26, 2012
March 5, 2012
December 2011
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01548092 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
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

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recto-vaginal Fistula
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
Experimental: Autologous SVF
Intralesional application
Intervention: Drug: Adipose-derived stem cells without expanded

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2013
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mariano Garcia Arranz +34912071022 mgarciaa.hulp@salud.madrid.org
Contact: Maria Dolores Herreos +34912071022 loles.herreros@gmail.com
Spain
 
NCT01548092
EC10-343, 2010-024330-35
No
Instituto de Investigación Hospital Universitario La Paz
Instituto de Investigación Hospital Universitario La Paz
Not Provided
Principal Investigator: Mariano García Arranz, PhD Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz
Instituto de Investigación Hospital Universitario La Paz
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP