Stress Urinary IncontinencePhase 1/2NCT01850342
Effectiveness and Safety of Cell-Assisted Lipotransfer for the Treatment of Stress Urinary Incontinence
A Phase 1/2 study testing Periurethral injection of fat micrograft enriched with ADRC in people with Stress Urinary Incontinence, run by Burnasyan Federal Medical Biophysical Center at 1 site in Russia.
Trial summary
Autologous washed and homogenized fat micrograft harvested from the patient's front abdominal wall enriched with adipose-derived regenerative cells (ADRC) derived by enzyme-treatment of a portion of the harvested fat. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Periurethral injection of fat micrograft enriched with ADRC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteRussia
- Study dates
- May 2013to Dec 2014
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient suffers from stress urinary incontinence due to insufficiency of the urethral sphincter at least for 2 years.
- Moderate and severe grade of urinary incontinence according to assessment made by investigator.
- Patient is familiar with Participant information sheet.
- Patient signed informed consent form.
Who cannot join
- Contraindications for local anesthesia.
- For the patients undergone surgical treatment of prostate cancer:
- Cancer relapse.
- prostate-specific antigen (PSA) level >0.008 ng/mL.
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia; Center for Biomedical Technologies
Moscow, 123182
About this study
Official title: Effectiveness and Safety of Cell-Assisted Lipotransfer for the Treatment of Stress Urinary Incontinence Via Endoscopically-Assisted Administration of Fat Tissue Micrografts Enriched by Autologous Adipose-Derived Regenerative Cells
Autologous washed and homogenized fat micrograft harvested from the patient's front abdominal wall enriched with adipose-derived regenerative cells (ADRC) derived by enzyme-treatment of a portion of the harvested fat. Fat tissue micrograft mixed with ADRC will be administered one-time endoscopically into submucosal layer of urethra under eye control. This is a single arm study with no control. All patients receive cell therapy.
Read the detailed description
Fat tissue obtainment. Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150 cc. Procedure time - 30 minutes.
ADRC isolation. Aspirated fat tissue placed into sterile tubes with transport medium and delivered into the laboratory within 15 minutes. To isolate the ADRC, part of lipoaspirate (approximately 100 cc) washed extensively with equal volumes of phosphate-buffered saline and digested with collagenase. After enzyme activity neutralization decomposed fat tissue eliminated and ADRC washed 3 times with saline. Cells divided into 3 portions. First portion used for counting, viability and sterility assessment. Second portion prepared for freezing in liquid nitrogen. Third portion mixed with fat micrograft.
Fat tissue enriched micrograft preparation. Obtained fat tissue (approximately 20-30 cc) washed repeatedly. Aspirated fat settled down in syringes placed in vertical position, after that liquid fraction eliminated. Syringes with fat filled up with Ringer's solution and procedure of settlement repeated 3-5 times. Washed fat placed on metallic mesh and mashed up using metallic spatula. Homogenized fat mixed with prepared ADRC and collected in syringe for further injection. Ratio fat micrograft/fat for ADRC estimated according to aspirate volume and usually forms 1:10. For example, ADRC obtained from 100 cc of fat tissue should be mixed with 10 cc of fat micrograft.
Fat micrograft preparation is also possible in Puregraft System (Cytori Therapeutics Inc) - closed disposable system for fat tissue selective washing.
Periurethral injection of fat micrograft enriched with ADRC Urethra punctured several times circle-wise at the bulbomembranous region at a depth of 5 mm under endoscopic vision and 0.5-1 mL of fat micrograft enriched with ADRC injected each time. Total volume of solution injected - approximately 8 mL. After fat micrograft injected, urethral balloon catheter placed and removed the following day.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Periurethral injection of fat micrograft enriched with ADRC
- Keywords
- Male stress urinary incontinence, Cell-assisted lipotransfer, Adipose-derived regenerative cells, ADRC, Micrograft, Fat tissue, 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.
Periurethral injection of fat micrograft enriched with ADRCProcedure or surgery
Subjects will undergo liposuction under local anesthesia. One part of lipoaspirate will be processed to isolate and concentrate ADRCs. Another part of lipoaspirate will be washed and homogenized to prepare fat tissue micrograft. After that fat tissue micrograft will be mixed with ADRC. Autologous fat micrograft enriched with ADRC will be injected at the bulbomembranous region of urethra circle-wise under endoscopic vision.
| Study group | Role | What they receive |
|---|---|---|
| Fat micrograft enhanced with ADRC | Experimental | Not described Receives: Procedure: Periurethral injection of fat micrograft enriched with ADRC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints
Types, probability and severity of treatment emergent serious adverse events (SAEs) and serious adverse reactions (SARs)
Measured: 4 weeks after treatment
Secondary outcomes (1)
Efficacy endpoints
- 24-hours pad test
- Urodynamic studies: maximal urethral closure pressure (MUCP), functional profile length (FPL), postvoid residual (PVR) volume measurement, uroflowmetry.
- Quality of life measured by the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF).
Measured: 2, 4, 8, 12, 16, 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014 (estimated)
- Study completionDec 2014 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burnasyan Federal Medical Biophysical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pavel Kyzlasov, Burnasyan Federal Medical Biophysical Center
- Investigators
- Ilya I Eremin, MD, PhD, Principal investigator, Burnasyan Federal Medical Biophysical CenterPavel S Kyzlasov, MD, Principal investigator, Burnasyan Federal Medical Biophysical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850342
- Sponsor's protocol ID
- RU-FMBC-01-01-13
- Status last verified
- May 2013
- First submitted
- 7 May 2013
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Cell-Assisted Lipotransfer for the Treatment of Stress Urinary Incontinence Via Endoscopically-Assisted Administration of Fat Tissue Micrografts Enriched by Autologous Adipose-Derived Regenerative Cells
- ClinicalTrials.gov ID
- NCT01850342
- Acronym / sponsor ID
- RU-FMBC-01-01-13
- Conditions
- Stress Urinary Incontinence
- Keywords
- Male stress urinary incontinence, Cell-assisted lipotransfer, Adipose-derived regenerative cells, ADRC, Micrograft, Fat tissue, Stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Burnasyan Federal Medical Biophysical CenterOther government
- Study start
- May 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 9 May 2013 (estimated)
- 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.
Autologous washed and homogenized fat micrograft harvested from the patient's front abdominal wall enriched with adipose-derived regenerative cells (ADRC) derived by enzyme-treatment of a portion of the harvested fat. Fat tissue micrograft mixed with ADRC will be administered one-time endoscopically into submucosal layer of urethra under eye control. This is a single arm study with no control. All patients receive cell therapy.
Detailed description
Fat tissue obtainment. Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150 cc. Procedure time - 30 minutes.
ADRC isolation. Aspirated fat tissue placed into sterile tubes with transport medium and delivered into the laboratory within 15 minutes. To isolate the ADRC, part of lipoaspirate (approximately 100 cc) washed extensively with equal volumes of phosphate-buffered saline and digested with collagenase. After enzyme activity neutralization decomposed fat tissue eliminated and ADRC washed 3 times with saline. Cells divided into 3 portions. First portion used for counting, viability and sterility assessment. Second portion prepared for freezing in liquid nitrogen. Third portion mixed with fat micrograft.
Fat tissue enriched micrograft preparation. Obtained fat tissue (approximately 20-30 cc) washed repeatedly. Aspirated fat settled down in syringes placed in vertical position, after that liquid fraction eliminated. Syringes with fat filled up with Ringer's solution and procedure of settlement repeated 3-5 times. Washed fat placed on metallic mesh and mashed up using metallic spatula. Homogenized fat mixed with prepared ADRC and collected in syringe for further injection. Ratio fat micrograft/fat for ADRC estimated according to aspirate volume and usually forms 1:10. For example, ADRC obtained from 100 cc of fat tissue should be mixed with 10 cc of fat micrograft.
Fat micrograft preparation is also possible in Puregraft System (Cytori Therapeutics Inc) - closed disposable system for fat tissue selective washing.
Periurethral injection of fat micrograft enriched with ADRC Urethra punctured several times circle-wise at the bulbomembranous region at a depth of 5 mm under endoscopic vision and 0.5-1 mL of fat micrograft enriched with ADRC injected each time. Total volume of solution injected - approximately 8 mL. After fat micrograft injected, urethral balloon catheter placed and removed the following day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fat micrograft enhanced with ADRC | Experimental | Procedure: Periurethral injection of fat micrograft enriched with ADRC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient suffers from stress urinary incontinence due to insufficiency of the urethral sphincter at least for 2 years.
- Moderate and severe grade of urinary incontinence according to assessment made by investigator.
- Patient is familiar with Participant information sheet.
- Patient signed informed consent form.
Key exclusion criteria (4 listed)
- Contraindications for local anesthesia.
- Cancer relapse.
- prostate-specific antigen (PSA) level >0.008 ng/mL.
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 |
|---|---|---|
| Periurethral injection of fat micrograft enriched with ADRCSubjects will undergo liposuction under local anesthesia. One part of lipoaspirate will be processed to isolate and concentrate ADRCs. Another part of lipoaspirate will be washed and homogenized to prepare fat tissue micrograft. After that fat tissue micrograft will be mixed with ADRC. Autologous fat micrograft enriched with ADRC will be injected at the bulbomembranous region of urethra circle-wise under endoscopic vision. | Procedure or surgery | Fat micrograft enhanced with ADRC |
Primary outcome
Safety endpoints
Time frame: 4 weeks after treatment
Types, probability and severity of treatment emergent serious adverse events (SAEs) and serious adverse reactions (SARs)
1 secondary outcome
Efficacy endpoints
Time frame: 2, 4, 8, 12, 16, 24 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2013.
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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.
Ilya I Eremin, MD, PhD principal investigator
Burnasyan Federal Medical Biophysical Center
Pavel S Kyzlasov, MD principal investigator
Burnasyan Federal Medical Biophysical Center
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 Periurethral injection of fat micrograft enriched with ADRC in people with Stress Urinary Incontinence, run by Burnasyan Federal Medical Biophysical Center at 1 site in Russia.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 May 2013. 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 Russia. 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?
Results are not available in the source record.
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?
Safety endpoints (time frame: 4 weeks after treatment). 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 9 May 2013.