Status:
UNKNOWN
Effectiveness and Safety of Cell-Assisted Lipotransfer for the Treatment of Stress Urinary Incontinence
Lead Sponsor:
Burnasyan Federal Medical Biophysical Center
Conditions:
Stress Urinary Incontinence
Eligibility:
MALE
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 t...
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 adip...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Contraindications for local anesthesia.
- For the patients undergone surgical treatment of prostate cancer:
- Cancer relapse.
- prostate-specific antigen (PSA) level \>0.008 ng/mL.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01850342
Start Date
May 1 2013
End Date
December 1 2014
Last Update
May 9 2013
Active Locations (1)
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1
State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia; Center for Biomedical Technologies
Moscow, Russia, 123182