WithdrawnNot Applicable

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

Stopped: recruitment issues

United States0Started 2021-10

Plain-language summary

This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction.

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * history of ED of at least 3 months' duration * have been taking a Phosphodiesterase type 5 (PDE5) inhibitor for at least 1 month prior and willing to stop taking any PDE5 inhibitor for duration of study * have an IIEF-EF domain score that is ≥11 and ≤25 * have the same sexual partner for the duration of the study * subject and partner willing to voluntarily give consent * speak, read and understand English Exclusion Criteria: * non-responders to PDE5 inhibitor * radical prostatectomy or other pelvic surgery or penile implant * currently taking blood thinners, cancer drugs or HIV drugs * allergic to lidocaine, epinephrine, valium * diminished decision-making capacity * use of tobacco * previous pelvic or abdominal radiation therapy * anti-androgen therapy * untreated hypogonadism * uncontrolled hypertension or hypotension * unstable cardiovascular disease * systemic autoimmune disorder

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Events

Timeframe: 1 year

Trial details

NCT IDNCT03886402

SponsorGID BIO, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10

View on ClinicalTrials.gov More Erectile Dysfunction trials