Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells

Study Overview
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Brief Summary
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Treatment of patients with urinary incontinence after prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

Detailed Description
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During the implementation of the project, it is planned to develop a method for the treatment of men urinary incontinence caused by prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen. The positive outlook for the effectiveness of MSCs is due to the following: the ability of MSCs to stimulate tissue regeneration positive results of preclinical studies of the method of treatment of urinary incontinence in animals. In study planing to include 5 patients. MSCs will be isolated from adipose tissue, cultured and then transplanted back to the periurethral area by five point injection in rhabdosphincter and submucosal space of urethra using the cystourethroscope. For injection in submucosal space MSCs (20*10^6 cells) will be mixed with collagen solution (3,5% w|w). Follow up patients monitoring will occur at 1，3，6 and 12 months after injection.

Official Title
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Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel and Injected Submucousely

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Biological: Autologous adipose-derived mesenchymal stem cells
* Other: Standard treatment according to the Clinical protocols


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Urinary incontinence absence of acute inflammatory manifestations in the genitourinary system period after prostatectomy is at least 12 months Exclusion Criteria: urethral or bladder malformations acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis mental disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cells<br>Patients with Urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells | Biological: Autologous adipose-derived mesenchymal stem cells<br>* Autologous adipose-derived mesenchymal stem cells mixed with collagen solution injected in submucosal space<br>Other: Standard treatment according to the Clinical protocols<br>* Standard treatment according to the Clinical protocols<br>|
| Active Comparator: control<br>Patients with Urinary incontinence receiving standard treatment | Other: Standard treatment according to the Clinical protocols<br>* Standard treatment according to the Clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cured patients | Number of patients cured | 3 months | 
| Number of patients with treatment-related adverse events | MSC application related adverse events assessed by blood count, liver and function tests | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary incontinence, Prostatectomy