- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04426643
Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells
Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel and Injected Submucousely
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
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Minsk, Belarus, 220072
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mesenchymal stem cells
Patients with Urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells
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Standard treatment according to the Clinical protocols
Autologous adipose-derived mesenchymal stem cells mixed with collagen solution injected in submucosal space
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Active Comparator: control
Patients with Urinary incontinence receiving standard treatment
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Standard treatment according to the Clinical protocols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with treatment-related adverse events
Time Frame: 4 weeks
|
MSC application related adverse events assessed by blood count, liver and function tests
|
4 weeks
|
Number of cured patients
Time Frame: 3 months
|
Number of patients cured
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3 months
|
Collaborators and Investigators
Investigators
- Study Director: Sergey A Krasny, Dr, Deputy Director for Research of the National Cancer Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBCE_MSC(UIM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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