NCT03518333

Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tissue Genesis · Industry
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Injection of adipose derived cells into penis	Injection of Icellator-derived cells

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-03-01
• Completion: 2023-09-01
• First posted: 2018-05-08
• Last updated: 2021-06-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study