Status:
UNKNOWN
Effectiveness and Safety of Autologous Adipose-Derived Regenerative Cells for the Treatment of Urethral Strictures
Lead Sponsor:
Burnasyan Federal Medical Biophysical Center
Conditions:
Urethral Strictures in Males
Eligibility:
MALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc)from a portion of the fat harvested from the patient's front abdominal wall. ADRC ...
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 urethral strictures at least for 1 year
- Moderate and severe grade of obstructive voiding symptoms 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 :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01889888
Start Date
June 1 2013
End Date
May 1 2015
Last Update
July 1 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