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Adipose-derived SVF for Treatment of Erectile Dysfunction (ED)

Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: GID BIO, Inc.
Must be taking: PDE5 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial will test if a single injection of cells taken from a man's own fat tissue can safely and effectively treat erectile dysfunction. It aims to help men who do not respond well to standard treatments by improving blood flow and repairing tissue. The cells have been investigated for their potential to treat erectile dysfunction by creating a pro-repair environment at the site of injury.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any PDE5 inhibitors (medications for erectile dysfunction) for the duration of the study. If you are currently taking blood thinners, cancer drugs, or HIV drugs, you cannot participate in the trial.

Eligibility Criteria

Inclusion Criteria

Both the subject and the partner are willing to give consent freely and voluntarily.
I can speak, read, and understand English.
I have been taking a phosphodiesterase type 5 inhibitor for at least 1 month prior, and I am willing to stop taking any phosphodiesterase type 5 inhibitor for the duration of the study.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of autologous adipose-derived stromal vascular fraction (SVF)

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Visits at 30 days, 3 months, and 6 months

Long-term follow-up

Monitoring of adverse events

1 year

Treatment Details

Interventions

  • GID SVF-2
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Each subject will receive a single injection of autologous adipose-derived stromal vascular fraction (SVF) and will be monitored for 6 months

Find a Clinic Near You

Who Is Running the Clinical Trial?

GID BIO, Inc.

Lead Sponsor

Trials
5
Recruited
190+