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

NCT ID: NCT03886402

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-10-31

Brief Summary

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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

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

GID SVF-2

Intervention Type DEVICE

Treatment of erectile dysfunction with the subjects own cells

Interventions

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GID SVF-2

Treatment of erectile dysfunction with the subjects own cells

Intervention Type DEVICE

Other Intervention Names

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GIDZyme-2-50 GID Procedure Pack

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GID BIO, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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David Matthews MD

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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GIDED-01

Identifier Type: -

Identifier Source: org_study_id

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