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Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO) (FLPURO)

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ClinicalTrials.gov Identifier: NCT01799694
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE February 27, 2013
Last Update Posted Date March 8, 2013
Study Start Date  ICMJE July 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2013)
Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery [ Time Frame: 16 weeks ]
Possibility of inject ASc by cystoscope
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2013)
Evaluate the feasability and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery [ Time Frame: 16 weeks ]
Possibility of inject ASc by cystoscope
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2013)
  • Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ]
    SF-12 questionnaire
  • Adverse events [ Time Frame: 1, 4, 16, 24 weeks ]
    Data collected
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2013)
  • Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ]
    SF-12 questionnare
  • Adverse events [ Time Frame: 1, 4, 16, 24 weeks ]
    Data collecte
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO)
Official Title  ICMJE Phase II Clinical Trial to Study the Feasibility and Safety of the Expanded Autologous Stem Cells Use Derived From Adipose Tissue (e-ASC) for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery
Brief Summary The purpose of this study is to evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE Drug: Inject of Autologous Adipose-derived stem cells
Inject in muscle of autologous adipose derived stem cells
Other Name: Autologuos eASC
Study Arms  ICMJE Experimental: Autologous Expanded Stem Cells
Inject of Autologous Adipose-derived expanded stem cells
Intervention: Drug: Inject of Autologous Adipose-derived stem cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2013)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent
  2. Men over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
  3. Prostate cancer diagnosed subjects via a biopsy and having had a radical surgery with a healing purpose in the previous 18 months
  4. Having urinary incontinence after the surgery
  5. Failure in any previous conservative treatment

Exclusion Criteria:

  1. Having had an adjuvant treatment
  2. Having a PSA ≥ 0,2 after surgery
  3. Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma
  4. Active urine infection
  5. Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
  6. Cardiopulmonary 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 acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
  9. Anesthetic allergy
  10. Major surgery or severe trauma in the previous 6 months
  11. Administration of any drug under experimentation in the present or in the previous 3 months before recruitment
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01799694
Other Study ID Numbers  ICMJE FLPURO-2009-01
2009-016298-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigación Hospital Universitario La Paz
Study Sponsor  ICMJE Instituto de Investigación Hospital Universitario La Paz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sergio Alonso Gregorio, MD Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz
PRS Account Instituto de Investigación Hospital Universitario La Paz
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP