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

March 7, 2013 updated by: Instituto de Investigación Hospital Universitario La Paz

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Autologuos eASC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessment using the SF-12 Questionnaire
Time Frame: 1, 4, 16, 24 weeks
SF-12 questionnaire
1, 4, 16, 24 weeks
Adverse events
Time Frame: 1, 4, 16, 24 weeks
Data collected
1, 4, 16, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Investigators

  • Principal Investigator: Sergio Alonso Gregorio, MD, Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

February 24, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLPURO-2009-01
  • 2009-016298-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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