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

Phase 1

Completed

• Conditions: Urinary Incontinence
• Interventions: Other: Standard treatment according to the Clinical protocols; Biological: Autologous adipose-derived mesenchymal stem cells

• Registration Number: NCT04426643
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-07
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-08-01
• Primary Completion: 2021-02-20
• Study Completion: 2021-03-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-24
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Standard treatment according to the Clinical protocols	Patients with Urinary incontinence receiving standard treatment
mesenchymal stem cells	Autologous adipose-derived mesenchymal stem cells	Patients with Urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells
mesenchymal stem cells	Standard treatment according to the Clinical protocols	Patients with Urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells

Primary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus