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

Not Applicable

Withdrawn

• Conditions: Erectile Dysfunction
• Interventions: Device: GID SVF-2

• Registration Number: NCT03886402
• Lead Sponsor: GID BIO, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Study Start: 2021-10
• Status Verified: 2022-08
• Primary Completion: 2022-10
• Study Completion: 2022-10
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	GID SVF-2	Each subject will receive a single injection of autologous adipose-derived stromal vascular fraction (SVF) and will be monitored for 6 months

Primary Outcome Measures

Name	Time	Method
Adverse Events	1 year	Monitoring of adverse events

Secondary Outcome Measures

Name	Time	Method
International Index of Erectile Function (IIEF)	Pre-treatment, 30 days, 3 months and 6 months	The IIEF is a brief 15-item, self-administered questionnaire that was developed as a measure to detect treatment-related erectile function in patients in cross-cultural settings. Instrument includes 5 domains; erectile function (EF), orgasmic function (OF), sexual desire (SD), intercourse satisfaction (IS) and overall satisfaction (OS). The sub-scales scores range as follows: Erectile Function: 1-30 Orgasmic Function: 0-10 Sexual Desire: 2-10 Intercourse Satisfaction: 0-15 Overall Satisfaction: 2-10 The items are not weighted and total scores range from 5 to 75. On the Erectile Function sub-scale lower scores indicate worse erectile dysfunction, while on the remaining sub-scales higher scores indicate less dysfunction

Trial Locations

Locations (1)

David Matthews MD; 🇺🇸 Charlotte, North Carolina, United States