Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction
Condition: Erectile Dysfunction; Impotence, Vasculogenic
MeSH terms: Erectile Dysfunction; Impotence, Vasculogenic
Study type: Interventional
Phase: Phase 1/Phase 2

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 will be administered one-time intracavernosally. This is a single arm
      study with no control. All patients receive cell therapy.
    

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
      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.
    

Intervention name(s): Intracavernosal administration of autologous ADRC; Liposuction; ADRC isolation
Intervention type(s): Other; Procedure; Device
Intervention description(s): Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After isolation autologous ADRC suspension will be injected intracavernosally.; ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADRC; Adipose-Derived Regenerative Cells; Fat Tissue; Stem Cells; Erectile Dysfunction; Arteriogenic Impotence; Venogenic Impotence; Vasculogenic Impotence; Male Impotence; Male Sexual Impotence