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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01548092
Recruitment Status : Unknown
Verified March 2012 by Instituto de Investigación Hospital Universitario La Paz.
Recruitment status was:  Recruiting
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Information provided by (Responsible Party):
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 recto-vaginal fistula.

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

Detailed Description:
SF-12 Test

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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 Recto-vaginal Fistula
Study Start Date : December 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ]
    Test SF-12 of quality of life

  2. Adverse events [ Time Frame: 1, 4, 12, 24 weeks ]
    Control by investigation team of CRD (data collections)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01548092

Contact: Mariano Garcia Arranz +34912071022
Contact: Maria Dolores Herreos +34912071022

Hospital Universitario La Paz Recruiting
Madrid, Spain, 28039
Contact: Mariano García Arranz    +34912071022   
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
Principal Investigator: Mariano García Arranz, PhD Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz

Herreros Marcos D, Garcia-Arranz M,Pascual Miguelañez I, Garcia-Olmo D. THE ROLE OF STEM CELLS IN SUPPURATIVE ENVIROMENTS. Experimental Dermatology 2006, 15 (6): 482
García Olmo D, Trébol J, Herreros D, Garcia-Arranz M, Gonzalez M. TREATMENT OF FISTULAS USING ADIPOSE-DERIVED STEM CELLS. En: García Olmo D, García-Verdugo JM, Alemany J, Gonzalez M, Gutierrez-Fuentes JA. CELL THERAPHY . Ed. Mac Graw Hill. Madrid 2007)
Garcia-Olmo, D; Guadalajara, H; Trebol, J, García-Arranz M. Expanded Adipose-Derived Stem Cells for the Treatment of Complex Perianal Fistula. HUMAN GENE THERAPY 2009. 20 (9):1028-1028
Trebol, J; Garcia-Arranz, M; Georgiev-Hristov, T, et al. Cell Therapy for Enterocutaneous Fistula Associated with Crohn's Disease: A Clinical and Biological Comparison of Protocols With and Without Cell Expansion. HUMAN GENE THERAPY 2009. 20 (9): 1045-1045
Garcia-Gomez, I; Olmedillas, S; Garcia-Arranz, M, et al. Adipose-Derived Stem Cells Reduce Abdominal Adhesion Formation in a Rat Experimental Model. HUMAN GENE THERAPY 2009. 20 (9): 1047-1047
Georgiev-Hristov, T; Garcia-Olmo, D; Alvarez, PDA, et al. Use of Surgical Sutures Enriched with Adipose-Derived Stem Cells for Tracheal Anastomosis in Rats. HUMAN GENE THERAPY 2009. 20 (9): 1074-1075
Vicente, A; Vazquez, MN; Entrena, A, Gqarcía-Arranz M,et al. BMP-4 Regulates the Expansion and Survival of Human Adipose Mesenchymal Cells. HUMAN GENE THERAPY .2009. 20 (9):1080-1081
Tihomir Georgiev-Hristov, M.D.; Ignacio García-Gómez, Ph.D.; Prudencio Díaz-Agero, M.D.; Luz Vega-Clemente; Jacobo Trébol, M.D.; Damián García-Olmo, M.D., Ph.D.; Mariano García-Arranz, Ph.D. "SUTURES ENRICHED WITH ADIPOSE-DERIVED STEM CELLS FOR ENHANCED HEALING OF TRACHEAL ANASTOMOSIS IN RATS" Histology and Histopathology. 2010 (UNDER REVISION)
García-Olmo D, Herreros D, De-La-Quintana P, Guadalajara H, Trébol J, Georgiev-Hristov T, García-Arranz M.

Responsible Party: Instituto de Investigación Hospital Universitario La Paz Identifier: NCT01548092     History of Changes
Other Study ID Numbers: EC10-343
2010-024330-35 ( EudraCT Number )
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

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

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