NCT04446884

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2020-06-25
• Last updated: 2020-06-25

Locations

1 site across 1 country: Belarus