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NCT04426643 Clinical Trial

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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04426643
Other study ID # IBCE_MSC(UIM)
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2020
Est. completion date March 31, 2021

Study information
Verified date May 2021
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 31, 2021
Est. primary completion date February 20, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells mixed with collagen solution injected in submucosal space
Other:
• Standard treatment according to the Clinical protocols
Standard treatment according to the Clinical protocols

Locations
Country Name City State
Belarus Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Minsk

Sponsors (2)
Lead Sponsor Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus The state institution N. N. Alexandrov National Cancer Centre of Belarus

Country where clinical trial is conducted

Belarus, 

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