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Completed

NCT Number: NCT04426643

Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells

Treatment of patients with urinary incontinence after prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

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Key information

Conditions

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 Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Minsk, 220072, Belarus

About this study

During the implementation of the project, it is planned to develop a method for the treatment of men urinary incontinence caused by prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen. The positive outlook for the 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 urinary incontinence in animals.

In study planing to include 5 patients. MSCs will be isolated from adipose tissue, cultured and then transplanted back to the periurethral area by five point injection in rhabdosphincter and submucosal space of urethra using the cystourethroscope. For injection in submucosal space MSCs (20*10^6 cells) will be mixed with collagen solution (3,5% w|w). Follow up patients monitoring will occur at 1，3，6 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

  • Urinary incontinence
  • absence of acute inflammatory manifestations in the genitourinary system
  • period after prostatectomy is at least 12 months

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 injected in submucosal space

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

Collaborators

  • N.N. Alexandrov National Cancer Centre

Registry information

Official study title

Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel and Injected Submucousely

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
May 25, 2021

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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