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

Phase 1

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Biological: Autologous adipose-derived mesenchymal stem cells; Other: Standard treatment according to the Clinical protocols

• Registration Number: NCT04446884
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary

Treatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

Detailed Description

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.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-06
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Last Update Submitted: 2020-06-22
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cells	Autologous adipose-derived mesenchymal stem cells	Patients with Stress urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells
mesenchymal stem cells	Standard treatment according to the Clinical protocols	Patients with Stress urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells
control	Standard treatment according to the Clinical protocols	Patients with Stress urinary incontinence receiving standard treatment

Primary Outcome Measures

Name	Time	Method
Number of cured patients	3 months	Number of patients cured
Number of patients with treatment-related adverse events	4 weeks	MSC application related adverse events assessed by blood count, liver and function tests

Trial Locations

Locations (1)

Hrodna City Clinical Hospital; 🇧🇾 Hrodna, Belarus