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Completed

NCT Number: NCT04446884

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

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

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hrodna City Clinical Hospital

Hrodna, 230009, Belarus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous adipose-derived mesenchymal stem cells

Biological

Autologous adipose-derived mesenchymal stem cells mixed with collagen solution

Standard treatment according to the Clinical protocols

Other

Standard treatment according to the Clinical protocols

Primary outcomes

  1. Number of cured patients

    Time frame: 3 months

    Number of patients cured

  2. Number of patients with treatment-related adverse events

    Time frame: 4 weeks

    MSC application related adverse events assessed by blood count, liver and function tests

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2020
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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