Erectile Dysfunction Clinical Trial
Official title:
Effectiveness and Safety of Intracavernosal Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction
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 intracavernosally. 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 insulin syringes with needle size 30 G for injection.
Intracavernosal injection of ADRC:
Tourniquet applied immediately prior to injection at the base of the penis. Penis and
surrounding skin treated with antiseptic solution. The injection performed on lateral
surface of penis bilaterally proximally into the middle and distal parts of corpus
cavernosum. Needle is inserted into the corpus cavernosum at the depth of 5-7 mm. Up to 1.0
ml of ADRC suspension injected per single injection. Equal portions of ADRC suspension
injected into both corpora cavernosa. Tourniquet removed 20 minutes after ADRC injection.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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