Urethral Strictures in Males Clinical Trial
Official title:
Effectiveness and Safety of Endoscopically-Assisted Submucosal Administration of Autologous Adipose-Derived Regenerative Cells for the Treatment of Urethral Strictures
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 will be administered one-time endoscopically into submucosal layer of urethra under eye control into the stricture site after mechanical dilation. This is a single arm study with no control. All patients receive cell therapy.
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 150-200 cc. Procedure time - 30 minutes.
ADRC isolation. Aspirated fat tissue placed into sterile vessel which inserted into Celution
800/CRS System (Cytori Therapeutics Inc) - closed system for automated and standardized
extraction and concentration of ADRC. Celution 800/CRS System drains excess of fluid from
fat tissue and estimate it's volume After that lipoaspirate washed extensively with equal
volumes of Ringer's solution to remove blood. At the end of this process System indicates
required volume of enzyme reagent (Celase®) which should be added immediately by operator.
After enzyme treatment Celution 800/CRS System automatically transfers isolated ADRC into
washing compartment where ADRC washed and concentrated in 5 mL suspension. Tissue processing
time - approximately 60 minutes. ADRC suspension match all requirements listed in technical
documentation for Celution 800/CRS System. Obtained ADRC divided into 2 portions. First
portion (0.2-0.5 mL) used for counting, viability and sterility assessment. Second portion
placed into sterile syringe for injection.
Urethral stricture dilation. Under direct vision HiWire® hydrophilic nitinol wire positioned
through the urethra and exchanged for a stiff-bodied wire. After that S-Curve urethral
dilators (Cook Medical Inc.) passed over the wire guide progressing from the smallest to the
largest 24(Fr) appropriate size while maintaining the wire guide's position.
Periurethral injection of ADRC. After dilation needle for injection introduced into urethra
using endoscope. Urethra punctured several times circle-wise at the region of stricture at
depth of 5 mm under endoscopic vision and 0.3-0.5 mL of ADRC suspension injected
submucosally each time. Total volume of solution injected depends on stricture length and
technical possibilities. Minimal injected volume - 3 mL, maximal - 4.5 ml. After fat
micrograft injected, urethral balloon catheter placed and removed the following day.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment