Clinical Trial of Autologous Adipose Derived Regenerative Cells for the Treatment of Male Stress Urinary Incontinence

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of periurethral injection of autologous Adipose Derived Regenerative Cells (ADRCs) in male stress urinary incontinence.

Official Title
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Open-label, Multi-center, Single Arm Study to Evaluate the Efficacy and Safety of Periurethral Injection of Autologous Adipose Derived Regenerative Cells (ADRCs) for the Treatment of Male Stress Urinary Incontinence

Conditions
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Urinary Incontinence , Stress

Intervention / Treatment
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* Biological: Periurethral injection of autologous ADRCs and adipose tissue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males with stress urinary incontinence with insufficient effect by behavioral therapy or pharmacotherapy persisting more than 1 year after either of the following surgical procedure: Patients with symptoms after radical prostatectomy for localized prostate cancer and currently without relapse/metastasis, and PSA level less than 0.1 ng/mL for over 1 year Patients with symptoms after transurethral prostatectomy or laser prostatectomy for prostatic hyperplasia, and PSA level less than 4.0 ng/mL over 1 year Age of 20 or above Mild to moderate urinary incontinence on the 24-hour pad test Patients who can keep a bladder diary in a satisfactory manner Patients who are willing and able to give signed consent Exclusion Criteria: - Concurrent with any other types of urinary incontinence History of urinary or reproductive surgery within 6 months History of behavioral therapy or pharmacotherapy within 3 months Concurrent with diabetes insipidus History of radiotherapy in the lower urinary tract History of ADRCs treatment for stress urinary incontinence History of any type of cell therapy within 6 months Participation in any other clinical trial within 3 months Concurrent with lower urinary tract obstruction Concurrent with urolithiasis, urinary tract infection or interstitial cystitis History of recurrent urinary tract infection History of malignant neoplasm within 5 years or a suspicion of it Life expectancy of less than 1 year Any other patients whom the trial investigator deemed ineligible to this study

Ages Eligible for Study
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Minimum Age: 20 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: ADRCs and Adipose tissue<br>Periurethral injection of autologous adipose derived regenerative cells and adipose tissue | Biological: Periurethral injection of autologous ADRCs and adipose tissue<br>* 1 mL of the isolated ADRC is injected into the region of the external urethral sphincter, and another 4 mL of the ADRC and 16mL autologous adipose cells is injected under the urethral mucosa.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test |  | Baseline and 52 weeks (LOCF) after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test |  | Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention | 
| Urine leakage volume by 24-hour pad test |  | Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention | 
| Rate of patients with improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline |  | Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention | 
| Number of incontinence episodes per day |  | Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention | 
| Number of pads used per day |  | Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention | 
| QOL score (ICIQ-SF and KHQ) |  | Baseline, 26 and 52 weeks after intervention | 
| Patient overall satisfaction |  | Baseline, 26 and 52 weeks after intervention | 
| Urodynamic parameters (MUCP, FPL and ALPP) |  | Baseline, 2, 4, 12, 26 and 52 weeks after intervention | 
| Blood flow at the injection site measured by transrectal ultrasonography |  | Baseline,12, 26 and 52 weeks after intervention | 
| Injection site evaluated by pelvis MRI scan |  | Baseline, 2, 26 and 52 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cell Transplantation