Trial record 19 of 125 for:    Open Studies | "Fistula"

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Garcia-Olmo D, Garcia-Arranz M, Herreros Marcos D, Pascual Miguelañez I. Fibrina y terapia celular en el tratamiento de la patología fistulosa en la enfermedad de Crohn. Protocolo y resultados de un ensayo clínico en fase I. Rev Esp Enferm Dig 2005. 97(Supl. II):51-54.)
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 .2008 Ed. Mac Graw Hill. Madrid 2007
D. Garcia-Olmo, D. Herreros, I. Pascual, J. M. Pascual, E. Del-Valle, J. Zorrilla, P. De-La-Quintana, M. Garcia-Arranz, M. Pascual. EXPANDED ADIPOSE-DERIVED STEM CELLS (CX401) FOR THE TREATMENT OF COMPLEX PERIANAL FISTULA. A PHASE II CLINICAL TRIAL. Gastroenterology 2008. A833
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
Garcia-Olmo D, Herreros D, Guadalajara H, Trebol J, Georgiev T, García-Arranz M.Adipose Derived Stem Cell for Treatment of Crohn´s fistula. Histology and Histopathology. 2011; 26(ss1):356

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
Digestive System Diseases
Digestive System Fistula
Gastrointestinal Diseases
Intestinal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 01, 2015