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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Drug: Inject of Autologous Adipose-derived stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Men over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination Prostate cancer diagnosed subjects via a biopsy and having had a radical surgery with a healing purpose in the previous 18 months Having urinary incontinence after the surgery Failure in any previous conservative treatment Exclusion Criteria: Having had an adjuvant treatment Having a PSA ≥ 0,2 after surgery Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma Active urine infection Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion Cardiopulmonary illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study Subjects with congenital or acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion Anesthetic allergy Major surgery or severe trauma in the previous 6 months Administration of any drug under experimentation in the present or in the previous 3 months before recruitment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Expanded Stem Cells<br>Inject of Autologous Adipose-derived expanded stem cells | Drug: Inject of Autologous Adipose-derived stem cells<br>* Inject in muscle of autologous adipose derived stem cells<br>* Other names: Autologuos eASC;|

What is the study measuring?
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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 | 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 | SF-12 questionnaire | 1, 4, 16, 24 weeks | 
| Adverse events | Data collected | 1, 4, 16, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary incontinence, Autologous expanded stem cells, Radical prostate cancer surgery