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 range18 Years – 65 Years

SexMALE

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

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