Erectile Dysfunction Clinical Trial
Official title:
Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction
This clinical study is designed to investigate the safety and potential ability of relocated autologous SVF (stromal vascular fraction) to restore erectile function in men with ED (erectile dysfunction).
Prospective, multi-center, two-arm, blinded, randomized treatment. Covariate adaptive randomization will be used. Covariates included in the adaptive randomization process will be investigational center, history of diabetes, and radical prostatectomy. The two randomized study arms are: 1. Treatment with SVF followed six months later with sham treatment (ARM 1) 2. Sham treatment followed six months later by treatment with SVF (ARM 2) Study population is 60 adult male subjects with organic erectile dysfunction (IIEF-EF score 11-22) of greater than 6 months' duration due to radical prostatectomy, diabetes mellitus, and/or vascular disease. Subjects will be followed for 12 months after initial treatment. ;
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