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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Urinary Incontinence Drug: Inject of Autologous Adipose-derived stem cells Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Autologous Expanded Stem Cells
Inject of Autologous Adipose-derived expanded stem cells
 Drug: Inject of Autologous Adipose-derived stem cells
Inject in muscle of autologous adipose derived stem cells
Other Name: Autologuos eASC


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ]
    SF-12 questionnaire

  2. Adverse events [ Time Frame: 1, 4, 16, 24 weeks ]
    Data collected


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799694


Locations
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Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
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Principal Investigator: Sergio Alonso Gregorio, MD Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz
More Information
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Publications:
Andriole GL, Grubb III LB, Buys SS et als. for the PLCO Project Team
García Olmo D, García-Verdugo JM, Alemany J, Gonzalez M, Gutierrez-Fuentes JA. CELL THERAPHY . Ed. Mac Graw Hill. Madrid 2007

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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01799694    
Other Study ID Numbers: FLPURO-2009-01
2009-016298-14 ( EudraCT Number )
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: September 2012
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Urinary incontinence
Autologous expanded stem cells
Radical prostate cancer surgery
Additional relevant MeSH terms:
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Prostatic Neoplasms
Urinary Incontinence
Enuresis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
 Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders