NCT04426643

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

June 7, 2020

Last Update Submit

May 24, 2021

Conditions

Urinary Incontinence

Keywords

Urinary incontinenceProstatectomy

Outcome Measures

Primary Outcomes (2)

  • Number of cured patients

    Number of patients cured

    3 months

  • Number of patients with treatment-related adverse events

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

    4 weeks

Study Arms (2)

mesenchymal stem cells

EXPERIMENTAL

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

Biological: Autologous adipose-derived mesenchymal stem cellsOther: Standard treatment according to the Clinical protocols

control

ACTIVE COMPARATOR

Patients with Urinary incontinence receiving standard treatment

Other: Standard treatment according to the Clinical protocols

Interventions

Autologous adipose-derived mesenchymal stem cellsBIOLOGICAL

Autologous adipose-derived mesenchymal stem cells mixed with collagen solution injected in submucosal space

mesenchymal stem cells
Standard treatment according to the Clinical protocolsOTHER

Standard treatment according to the Clinical protocols

controlmesenchymal stem cells

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • urethral or bladder malformations
  • acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
  • mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Igor D Volotovski, Dr

    Head of the Lab of Institute of Biophysics and Cell Engineering

    STUDY DIRECTOR

  • Sergey A Krasny, Dr

    Deputy Director for Research of the National Cancer Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 11, 2020

Study Start

August 1, 2020

Primary Completion

February 20, 2021

Study Completion

March 31, 2021

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)