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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 26, 2012

Last Updated Date

March 5, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01548092 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

SF-12 Test

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Recto-vaginal Fistula

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Autologous SVF

Intralesional application

Intervention: Drug: Adipose-derived stem cells without expanded

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01548092

Other Study ID Numbers ^ICMJE

EC10-343, 2010-024330-35

Has Data Monitoring Committee

Responsible Party

Instituto de Investigación Hospital Universitario La Paz

Study Sponsor ^ICMJE

Instituto de Investigación Hospital Universitario La Paz

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mariano García Arranz, PhD

Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz

Information Provided By

Instituto de Investigación Hospital Universitario La Paz

Verification Date

March 2012

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

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