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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Autologous adipose-derived mesenchymal stem cells
Standard treatment according to the Clinical protocols
Sponsored by
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary incontinence, Prostatectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mesenchymal stem cells

control

Arm Description

Patients with Urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells

Patients with Urinary incontinence receiving standard treatment

Outcomes

Primary Outcome Measures

Number of cured patients
Number of patients cured
Number of patients with treatment-related adverse events
MSC application related adverse events assessed by blood count, liver and function tests

Secondary Outcome Measures

Full Information

First Posted
June 7, 2020
Last Updated
May 24, 2021
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
The state institution N. N. Alexandrov National Cancer Centre of Belarus
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1. Study Identification

Unique Protocol Identification Number
NCT04426643
Brief Title
Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells
Official Title
Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel and Injected Submucousely
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
The state institution N. N. Alexandrov National Cancer Centre of Belarus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary incontinence, Prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mesenchymal stem cells
Arm Type
Experimental
Arm Description
Patients with Urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells
Arm Title
control
Arm Type
Active Comparator
Arm Description
Patients with Urinary incontinence receiving standard treatment
Intervention Type
Biological
Intervention Name(s)
Autologous adipose-derived mesenchymal stem cells
Intervention Description
Autologous adipose-derived mesenchymal stem cells mixed with collagen solution injected in submucosal space
Intervention Type
Other
Intervention Name(s)
Standard treatment according to the Clinical protocols
Intervention Description
Standard treatment according to the Clinical protocols
Primary Outcome Measure Information:
Title
Number of cured patients
Description
Number of patients cured
Time Frame
3 months
Title
Number of patients with treatment-related adverse events
Description
MSC application related adverse events assessed by blood count, liver and function tests
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor D Volotovski, Dr
Organizational Affiliation
Head of the Lab of Institute of Biophysics and Cell Engineering
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sergey A Krasny, Dr
Organizational Affiliation
Deputy Director for Research of the National Cancer Centre
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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