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

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Other: Standard treatment according to the Clinical protocols; Biological: Autologous adipose-derived mesenchymal stem cells

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belarus
  • Hrodna, Belarus, 230009
    • Hrodna City Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mesenchymal stem cells; Patients with Stress urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells	Other: Standard treatment according to the Clinical protocols; Standard treatment according to the Clinical protocols; Biological: Autologous adipose-derived mesenchymal stem cells; Autologous adipose-derived mesenchymal stem cells mixed with collagen solution
Active Comparator: control; Patients with Stress urinary incontinence receiving standard treatment	Other: Standard treatment according to the Clinical protocols; Standard treatment according to the Clinical protocols

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Investigators: Study Director: Alexander Nechiporenko, Dr, Associate Professor of Department of Surgical Diseases

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Stress Urinary Incontinence; Mesenchymal stem cells
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: IBCE_MSC(UIW)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No