Erectile DysfunctionNCT03886402
Adipose-derived SVF for Treatment of Erectile Dysfunction (ED)
A study testing GID SVF-2 in people with Erectile Dysfunction, run by GID BIO, Inc. at 1 site in United States.
Trial summary
This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- GID SVF-2
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- previous pelvic or abdominal radiation therapy
- anti-androgen therapy
- untreated hypogonadism
- uncontrolled hypertension or hypotension
- unstable cardiovascular disease
- systemic autoimmune disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Erectile Dysfunction
- Being tested
- GID SVF-2
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GID SVF-2Device
Also called GIDZyme-2-50, GID Procedure Pack
Treatment of erectile dysfunction with the subjects own cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Each subject will receive a single injection of autologous adipose-derived stromal vascular fraction (SVF) and will be monitored for 6 months Receives: Device: GID SVF-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Monitoring of adverse events
Measured: 1 year
Secondary outcomes (1)
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
Measured: Pre-treatment, 30 days, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GID BIO, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886402
- Sponsor's protocol ID
- GIDED-01
- Status last verified
- Aug 2022
- First submitted
- 18 Mar 2019
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Erectile Dysfunction - A Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT03886402
- Acronym / sponsor ID
- GIDED-01
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: recruitment issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GID BIO, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: GID SVF-2Each subject will receive a single injection of autologous adipose-derived stromal vascular fraction (SVF) and will be monitored for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GID SVF-2Also: GIDZyme-2-50, GID Procedure PackTreatment of erectile dysfunction with the subjects own cells | Device | Treatment |
Primary outcome
Adverse Events
Time frame: 1 year
Monitoring of adverse events
1 secondary outcome
International Index of Erectile Function (IIEF)
Time frame: Pre-treatment, 30 days, 3 months and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GID SVF-2 in people with Erectile Dysfunction, run by GID BIO, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.