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

GID BIO

Status: Withdrawn

Conditions: Erectile Dysfunction

Treatments: Device: GID SVF-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03886402

GIDED-01

Details and patient eligibility

About

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

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment

Experimental group

Description:

Each subject will receive a single injection of autologous adipose-derived stromal vascular fraction (SVF) and will be monitored for 6 months

Treatment:

Device: GID SVF-2