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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 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:
NCT01584713
First received: February 26, 2012
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Enterocutaneous 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 Enterocutaneous 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 enterocutaneous fistulae. Percentage of treated subjects with closed fistulae [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Safety by analyzing the number of adverse effects associated with experimental treatment.


Secondary Outcome Measures:
  • quality of life test [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    Test SF 12 of quality of life

  • First efficacy data [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Fistula closure by radiology


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: 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 Name: Non applicable

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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584713

Contacts
Contact: Mariano Garcia Arranz +34912071022 mgarciaa.hulp@salud.madrid.org
Contact: Héctor Guadalajara Labajo +34912071022 h.guadalajara@gmail.com

Locations
Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Mariano García Arranz    +34912071022    mgarciaa.hulp@salud.madrid.org   
Sub-Investigator: Héctor Guadalajara Labajo         
Sub-Investigator: Damián García Olmo         
Sub-Investigator: Tihomir G Hirstov         
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
  More Information

Publications:
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 .2008 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
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
Pascual I, Fernández de Miguel G, García Arranz M, García-Olmo D. Biosutures improve healing of experimental weak colonic anastomoses. Int J Colorectal Dis. 2010; 25(12): 1447-1451
García-Gómez I, Elvira G, Zapata AG, Lamana ML, Ramírez M, García Castro J, García-Arranz M, Vicente A, Bueren J, García-Olmo D. Mesenchymal stem cells: biological properties and clinical applications. Expert Opin Biol Ther. 2010
Vicente López MA, Vázquez García MN, Entrena A, Olmedillas Lopez S, García-Arranz M, García-Olmo D, Zapata A..Low Doses of Bone Morphogenetic Protein 4 Increase the Survival of Human Adipose-Derived Stem Cells Maintaining Their Stemness and Multipotency. Stem Cells Dev. 2010
Lopez JT, Hristov TG, García-Arranz M, García-Olmo D..Stem Cell Therapy for Digestive Tract Diseases: Current State and Future Perspectives. Stem Cells Dev. 2011 Feb 17

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01584713     History of Changes
Other Study ID Numbers: EC10-345, 2010-024308-82
Study First Received: February 26, 2012
Last Updated: April 23, 2012
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Fistula
Intestinal Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 16, 2014