Adipose-derived SVF for Treatment of Erectile Dysfunction (ED)
NCT ID: NCT03886402
Last Updated: 2025-04-24
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2021-10-31
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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
GID SVF-2
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
MALE
Yes
Sponsors
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GID BIO, Inc.
INDUSTRY
Responsible Party
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Locations
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David Matthews MD
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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GIDED-01
Identifier Type: -
Identifier Source: org_study_id
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