Stress Urinary IncontinencePhase 1/2NCT04446884
Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells
A Phase 1/2 study testing Autologous adipose-derived mesenchymal stem cells and Standard treatment according to the Clinical protocols in people with Stress Urinary Incontinence, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Autologous adipose-derived mesenchymal stem cells and Standard treatment according to the Clinical protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Mar 2018to 31 Dec 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stress urinary incontinence
- absence of acute inflammatory manifestations in the genitourinary system
Who cannot join
- urethral or bladder malformations
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel
Treatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel
Read the detailed description
During the implementation of the project, method for the treatment of women stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen was developed.
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
- Stress Urinary Incontinence
- Being tested
- Autologous adipose-derived mesenchymal stem cells, Standard treatment according to the Clinical protocols
- Keywords
- Stress Urinary Incontinence, Mesenchymal stem cells
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose-derived mesenchymal stem cellsBiological
Autologous adipose-derived mesenchymal stem cells mixed with collagen solution
Standard treatment according to the Clinical protocolsOther
Standard treatment according to the Clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Patients with Stress urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells Receives: Biological: Autologous adipose-derived mesenchymal stem cells; Other: Standard treatment according to the Clinical protocols |
| control | Active comparator | Patients with Stress urinary incontinence receiving standard treatment Receives: Other: Standard treatment according to the Clinical protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cured patients
Number of patients cured
Measured: 3 months
Number of patients with treatment-related adverse events
MSC application related adverse events assessed by blood count, liver and function tests
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Mar 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Igor D Volotovski, Prof, Study director, Head of the Lab of Institute of Biophysics and Cell EngineeringAlexander Nechiporenko, Dr, Study director, Associate Professor of Department of Surgical Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446884
- Sponsor's protocol ID
- IBCE_MSC(UIW)
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel
- ClinicalTrials.gov ID
- NCT04446884
- Acronym / sponsor ID
- IBCE_MSC(UIW)
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress Urinary Incontinence, Mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel
Detailed description
During the implementation of the project, method for the treatment of women stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen was developed.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Biological: Autologous adipose-derived mesenchymal stem cells, Other: Standard treatment according to the Clinical protocolsPatients with Stress urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells |
| control | Active comparator | Other: Standard treatment according to the Clinical protocolsPatients with Stress urinary incontinence receiving standard treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stress urinary incontinence
- absence of acute inflammatory manifestations in the genitourinary system
Key exclusion criteria (3 listed)
- urethral or bladder malformations
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous adipose-derived mesenchymal stem cellsAutologous adipose-derived mesenchymal stem cells mixed with collagen solution | Biological | mesenchymal stem cells |
| Standard treatment according to the Clinical protocolsStandard treatment according to the Clinical protocols | Other | control, mesenchymal stem cells |
Primary outcome
Number of cured patients
Time frame: 3 months
Number of patients cured
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor D Volotovski, Prof study director
Head of the Lab of Institute of Biophysics and Cell Engineering
Alexander Nechiporenko, Dr study director
Associate Professor of Department of Surgical Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous adipose-derived mesenchymal stem cells and Standard treatment according to the Clinical protocols in people with Stress Urinary Incontinence, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cured patients (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.