Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)

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:
NCT01586715
First received: April 23, 2012
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae.


Condition Intervention Phase
Extremely Complex Perianal Fistulae
Drug: Adipose-derived stem cells without expanded
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 IIa Clinical Trial to Study the Treatment of the Extremely Complex and Conventional Treatment Resistant Perianal Fistulae With Autologous Stem Cells From Lipoaspirate

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 extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Stem Cells Drug: Adipose-derived stem cells without expanded
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Extremely Complex perianal fistulae
  • Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
  • Previous failure in at least one closing fistula standard treatment

Exclusion Criteria:

  • Presence of severe proctitis or dominant active luminal disease requiring immediate 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: NCT01586715

Contacts
Contact: Damián García Olmo, Prof MD 0034 912071022 damian.garcia@uam.es
Contact: Mariano A García Arranz, PhD 0034 912071022 mgarciaa.hulp@salud.madrid.org

Locations
Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Mariano A García Arranz, PhD    0034 912071022    mgarciaa.hulp@salud.madrid.org   
Principal Investigator: Damián García Olmo, Prof MD         
Sub-Investigator: Héctor Guadalajara Labajo, MD         
Sub-Investigator: Tihomir G Hirstov, MD         
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
Principal Investigator: Damián García Olmo, Prof MD General Surgery Department (Hospital Universitario La Paz) and Cell Therapy laboratory
  More Information

Publications:
Tuxen PA, Castro AF. Rectovaginal fistula in Crohn´s disease. Dis Colon Rectum.1979; 22:58-62
Andreani SM, Dang HM, Grodona P, Khan AZ, Edwards DP. Rectovaginal fistula in Crohn´s disease. 2007; 50(12): 2215-2222

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01586715     History of Changes
Other Study ID Numbers: HULPCIR-2010-01, 2010-024329-19
Study First Received: April 23, 2012
Last Updated: April 25, 2012
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on September 14, 2014