Stress Urinary Incontinence Clinical Trial
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
Verified date | May 2013 |
Source | Burnasyan Federal Medical Biophysical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Russia: Ethics Committee |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 12 |
Est. completion date | December 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - Contraindications for local anesthesia. For the patients undergone surgical treatment of prostate cancer: - Cancer relapse. - prostate-specific antigen (PSA) level >0.008 ng/mL. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia; Center for Biomedical Technologies | Moscow |
Lead Sponsor | Collaborator |
---|---|
Burnasyan Federal Medical Biophysical Center |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety endpoints | Types, probability and severity of treatment emergent serious adverse events (SAEs) and serious adverse reactions (SARs) | 4 weeks after treatment | Yes |
Secondary | 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). |
2, 4, 8, 12, 16, 24 weeks after treatment | No |
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