Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Study Overview
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Brief Summary
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Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.

Detailed Description
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Autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for multiplication and after about 6 weeks time will be injected into the subjects urethra.

Official Title
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Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Muscle Biopsy
* Biological: Injection of autologous stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: urinary incontinence failed urinary incontinence (UI) treatments Exclusion Criteria: - does not meet inclusion criteria, gender and age limit

Ages Eligible for Study
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Minimum Age: 78 Years
Maximum Age: 82 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: Stem Cell treatment<br>Muscle Biopsy and Injection of autologous stem cells | Procedure: Muscle Biopsy<br>* Biopsy of thigh muscle to obtain stem cell core.<br>Biological: Injection of autologous stem cells<br>* After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study-Related Adverse Events |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire | The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible. | Baseline and 6 months | 
| Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA) | The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse. | 6 months | 
| Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I) | The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Very Much Better, 2 Much Better, 3 A Little Better, 4 No Change, 5 A Little Worse, 6 Much Worse, and 7 Very Much Worse. | 6 months |