Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells
NCT ID: NCT04446884
Last Updated: 2020-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2018-03-01
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness and Safety of Cell-Assisted Lipotransfer for the Treatment of Stress Urinary Incontinence
NCT01850342
Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence
NCT02334878
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
NCT00847535
Autologous Muscle Derived Stem Cells Transplantation in Urine Incontinency
NCT01963455
The Efficacy and Safety of Fotona Smooth® Device for the Treatment of Stress Urinary Incontinence
NCT03098992
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 stress urinary incontinence (SUI) in animals (female rats).
After gynecological examination, diagnosis of SUI, MSCs were isolated from adipose tissue, cultured and then transplanted back to directly under mucosa of urethra by three point injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the paraurethral area.
Injected volume was 3 ml per patient. For injection MSCs (6\*10\^6 cells) were mixed with collagen solution (3,5% w\|w).
Follow up patients monitoring was mperformed at 2, 4, 6 and 12 months after injection.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
mesenchymal stem cells
Patients with Stress urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells mixed with collagen solution
Standard treatment according to the Clinical protocols
Standard treatment according to the Clinical protocols
control
Patients with Stress urinary incontinence receiving standard treatment
Standard treatment according to the Clinical protocols
Standard treatment according to the Clinical protocols
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells mixed with collagen solution
Standard treatment according to the Clinical protocols
Standard treatment according to the Clinical protocols
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* absence of acute inflammatory manifestations in the genitourinary system
Exclusion Criteria
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
18 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Igor D Volotovski, Prof
Role: STUDY_DIRECTOR
Head of the Lab of Institute of Biophysics and Cell Engineering
Alexander Nechiporenko, Dr
Role: STUDY_DIRECTOR
Associate Professor of Department of Surgical Diseases
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hrodna City Clinical Hospital
Hrodna, , Belarus
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IBCE_MSC(UIW)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.