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
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Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
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
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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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
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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
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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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 |
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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 |