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

GID BIO, Inc.

Overview

This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Erectile Dysfunction

Interventions

GID SVF-2DEVICE

Treatment of erectile dysfunction with the subjects own cells

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

David Matthews MD

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Adverse Events

Monitoring of adverse events

Time frame: 1 year

Secondary Outcomes

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

Time frame: Pre-treatment, 30 days, 3 months and 6 months

Data from ClinicalTrials.gov

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