Erectile Dysfunction
Conditions
Brief summary
This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction.
Interventions
DEVICEGID SVF-2
Treatment of erectile dysfunction with the subjects own cells
Sponsors
GID BIO, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 year | Monitoring of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function (IIEF) | Pre-treatment, 30 days, 3 months and 6 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Partner Satisfaction Questionnaire | Pre-treatment and 30 days, 3 months and 6 months | 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. |
Countries
United States
Outcome results
None listed