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NCT04446884 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04446884
Other study ID # IBCE_MSC(UIW)
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2018
Est. completion date December 31, 2019

Study information
Verified date June 2020
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells mixed with collagen solution
Other:
• Standard treatment according to the Clinical protocols
Standard treatment according to the Clinical protocols

Locations
Country Name City State
Belarus Hrodna City Clinical Hospital Hrodna

Sponsors (1)
Lead Sponsor Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Country where clinical trial is conducted

Belarus, 

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