Clinical Trial: Evaluate the Use of Liposuction and Cell Separation Devices for Autologous Fat (Adipose) Derived Cells to Treat the Symptoms of Erectile Dysfunction
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Evaluate the Use of Liposuction and Cell Separation Devices for Autologous Fat (Adipose) Derived Cells to Treat the Symptoms of Erectile Dysfunction
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of adipose derived cells for the treatment of erectile dysfunction symptoms.
Detailed Summary: This trial is being conducted to determine the safety and efficacy of injecting autologous adipose derived cells into the penis of men with erectile dysfunction. Subjects will be randomized into a treatment and control arm.
Sponsor: Tissue Genesis, LLC
Current Primary Outcome:
- Adverse Events that occur during or after the procedure to measure safety and tolerability [ Time Frame: 3 years ]
- Erectile function [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Continence [ Time Frame: 3 years ]
- Treatment assessment [ Time Frame: 3 years ]
- Erection hardness [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Tissue Genesis, LLC
Dates:
Date Received: May 9, 2012
Date Started: May 2012
Date Completion: May 2017
Last Updated: August 29, 2016
Last Verified: August 2016
