Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells

Study Overview
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Brief Summary
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Treatment of women with stress urinary incontinence 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, method for the treatment of women stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen was developed. 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 stress urinary incontinence (SUI) in animals (female rats). After gynecological examination, diagnosis of SUI, MSCs were isolated from adipose tissue, cultured and then transplanted back to directly under mucosa of urethra by three point injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the paraurethral area. Injected volume was 3 ml per patient. For injection MSCs (6*10^6 cells) were mixed with collagen solution (3,5% w|w). Follow up patients monitoring was mperformed at 2, 4, 6 and 12 months after injection.

Official Title
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Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel

Conditions
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Stress 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: Stress urinary incontinence absence of acute inflammatory manifestations in the genitourinary system 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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Female

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 Stress 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<br>Other: Standard treatment according to the Clinical protocols<br>* Standard treatment according to the Clinical protocols<br>|
| Active Comparator: control<br>Patients with Stress 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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Stress Urinary Incontinence, Mesenchymal stem cells