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

Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Erectile Dysfunction - A Safety and Feasibility Study

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

Study Overview

• Status: Withdrawn
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Device: GID SVF-2

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • David Matthews MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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; Treatment of erectile dysfunction with the subjects own cells; Other Names: GIDZyme-2-50; GID Procedure Pack

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Monitoring of adverse events	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Index of Erectile Function (IIEF)	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	Pre-treatment, 30 days, 3 months and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partner Satisfaction Questionnaire	This questionnaire asks the partner for their perceptions of effectiveness and overall satisfaction with the SVF treatment their partner received for erectile dysfunction. The questionnaire consists of 7 Likert scale questions (1 - 5), with a total score range of 7 to 35 with higher scores indicating more satisfaction. There are no subscales.	Pre-treatment and 30 days, 3 months and 6 months

Collaborators and Investigators

• Sponsor: GID BIO, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2021
• Primary Completion (Estimated): October 1, 2022
• Study Completion (Estimated): October 1, 2022

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction
• Other Study ID Numbers: GIDED-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No