NCT04446884

Brief Summary

Treatment of women with stress urinary incontinence 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 Mar 2018

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

Study Start

First participant enrolled

March 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

1.8 years

First QC Date

June 22, 2020

Last Update Submit

June 22, 2020

Conditions

Stress Urinary Incontinence

Keywords

Stress Urinary IncontinenceMesenchymal stem cells

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 Stress 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 Stress 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

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
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stress urinary incontinence
  • absence of acute inflammatory manifestations in the genitourinary system

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)

Hrodna City Clinical Hospital

Hrodna, 230009, Belarus

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination 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, Prof

    Head of the Lab of Institute of Biophysics and Cell Engineering

    STUDY DIRECTOR

  • Alexander Nechiporenko, Dr

    Associate Professor of Department of Surgical Diseases

    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 22, 2020

First Posted

June 25, 2020

Study Start

March 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 25, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)