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

Study Overview
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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.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: GID SVF-2


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* Treatment of erectile dysfunction with the subjects own cells<br>* Other names: GID Procedure Pack;|

What is the study measuring?
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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 |