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

NCT03886402 | Withdrawn FDA Device

• 1 other identifier: GIDED-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Monitoring of adverse events

  1 year

Secondary Outcomes (1)

• International Index of Erectile Function (IIEF)

  Pre-treatment, 30 days, 3 months and 6 months

Other Outcomes (1)

• Partner Satisfaction Questionnaire

  Pre-treatment and 30 days, 3 months and 6 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: GID SVF-2

Interventions

GID SVF-2 DEVICE

Treatment of erectile dysfunction with the subjects own cells

Also known as: GIDZyme-2-50, GID Procedure Pack

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GID BIO, Inc.: lead

Study Sites (1)

David Matthews MD

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 22, 2019
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 24, 2025

Record last verified: 2022-08

Locations

US (1)