Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Instituto de Investigación Hospital Universitario La Paz
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT01804153
First received: September 4, 2012
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence


Condition Intervention Phase
Urinary Incontinence
Drug: Adipose-derived expanded stem cells
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: Phase II Clinical Trial to Study the Feasibility and Safety of the Expanded Autologous Mesenchymal Stem Cells Use Derived From Adipose Tissue (ASC) for the Local Feminine Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Instituto de Investigación Hospital Universitario La Paz:

Primary Outcome Measures:
  • Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    compress test (number dthe changes daily) urethrocystoscopy (morphology of urethra)


Secondary Outcome Measures:
  • Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ] [ Designated as safety issue: Yes ]
    SF-12 questionnaire

  • Adverse events [ Time Frame: 1, 4, 16, 24 weeks ] [ Designated as safety issue: Yes ]
    Data collection


Estimated Enrollment: 10
Study Start Date: September 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous expanded stem cells
Adipose-derived expanded stem cells
Drug: Adipose-derived expanded stem cells
Intralesional application ASC

Detailed Description:

Evaluate safety of adipose derived stem cells to femenine urinary incontinence with local application

  Eligibility

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

Inclusion Criteria:

  1. -Signed informed consen
  2. -Good general state of health according to the findings of ythe clinical history and the physical examination
  3. -Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide
  4. -Women having rejected de rehabilitation treatment or in which the treatment had failed
  5. -Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution

Exclusion Criteria:

  1. -Pregnant or lactating women
  2. -Active urine infection
  3. -Presenting an infravesical obstruction
  4. -Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
  5. -Presenting any other malignant neoplasia unless it is a basocellar or a skin epidermoide carcinoma or presents antecedents of malignant tumours, unless they are in a remission phase for the previous 5 years
  6. -Cardiopulmonar illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study
  7. -Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study
  8. -Subjects with congenital or aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
  9. -Anesthesic allergy
  10. -Major surgery or severe trauma in the previous 6 months
  11. -Administration of any drug under experimentation in the present or 3 months before recruitement
  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: NCT01804153

Contacts
Contact: Mariano García-Arranz, PhD 0034 912071022 mgarciaa.hulp@salud.madrid.org
Contact: Sergio Alonso Gregorio, MD 0034 912071022 garavelos@terra.es

Locations
Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Mariano García-Arranz, PhD    0034 912071022    mgarciaa.hulp@salud.madrid.org   
Principal Investigator: Sergio Alonso Gregorio, MD         
Sub-Investigator: Mariano García-Arranz, MD         
Sub-Investigator: Damián García Olmo, MD         
Sub-Investigator: Fernando de Miguel Pedrero, MD         
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
Principal Investigator: Sergio Alonso Gregorio, MD Hospital Universitario La Paz
  More Information

Publications:
Zhao W, Zhang C, Jin C, Zhang Z, Kong D, Xu W, Xiu Y. Periurethral injection of autologous adipose-derived stem cells with controlled-release nerve growth factor for the treatment of stress urinary incontinence in a rat model. Eur Urol. 2011;59(1):155-63

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01804153     History of Changes
Other Study ID Numbers: HULPURO-2010-01, 2010-024331-16
Study First Received: September 4, 2012
Last Updated: March 1, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Feminine stress urinary incontinence
Autologous expanded stem cells

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014