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

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stress Urinary Incontinence

Treatments: Other: Standard treatment according to the Clinical protocols; Biological: Autologous adipose-derived mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04446884

IBCE_MSC(UIW)

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

mesenchymal stem cells

Experimental group

Description:

Patients with Stress urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells

Treatment:

Other: Standard treatment according to the Clinical protocols

Biological: Autologous adipose-derived mesenchymal stem cells

control

Active Comparator group

Description:

Patients with Stress urinary incontinence receiving standard treatment

Treatment:

Other: Standard treatment according to the Clinical protocols