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

Sponsor
GID BIO, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT03886402
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
10
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: GID SVF-2
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site studyThis is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Erectile Dysfunction - A Safety and Feasibility Study
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

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
Treatment of erectile dysfunction with the subjects own cells
Other Names:
  • GIDZyme-2-50
  • GID Procedure Pack

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [1 year]

      Monitoring of adverse events

    Secondary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 David Matthews MD Charlotte North Carolina United States 28203

    Sponsors and Collaborators

    • GID BIO, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GID BIO, Inc.
    ClinicalTrials.gov Identifier:
    NCT03886402
    Other Study ID Numbers:
    • GIDED-01
    First Posted:
    Mar 22, 2019
    Last Update Posted:
    May 3, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of May 3, 2021