Clinical Trial: Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness and Safety of Intracavernosal Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction

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

Detailed Summary:

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:

Sponsor: Central Clinical Hospital with Outpatient Health Center of Business Administration for the President

Current Primary Outcome:

• SAEs monitoring [ Time Frame: 2 weeks after treatment ]
  Types, probability and severity of treatment emergent serious adverse events (SAEs)
• SARs monitoring [ Time Frame: 2 weeks after treatment ]
  Types, probability and severity of treatment emergent serious adverse reactions (SARs)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Quality of life monitoring [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
  Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), International Index of Erectile Function (IIEF-5), Sexual Encounter Profile (SEP), Erection Hardness Score (EHS), Global Assessment Question (GAQ)
• Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
  Colour penile Doppler ultrasonography with intracavernosal injection of prostaglandin-E1 10 ug. Arterial diameter, peak systolic flow velocity, end diastolic flow velocity and resistance index measured before and 15 min after prostaglandin-E1 10ug intracavernosal injection.
• Endothelial function assessment [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
  Endothelial function assessed by EndoPAT or similar device measurements.
• Arterial stiffness assessment [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
  Arterial stiffness assessed by EndoPAT or similar device measurements.

Original Secondary Outcome: Same as current

Information By: Central Clinical Hospital with Outpatient Health Center of Business Administration for the President

Dates:
Date Received: June 9, 2015
Date Started: April 2015
Date Completion:
Last Updated: November 29, 2016
Last Verified: November 2016