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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886402
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
GID BIO, Inc.

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
Erectile Dysfunction Device: GID SVF-2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 1 year ]
    Monitoring of adverse events


Secondary Outcome Measures :
  1. International Index of Erectile Function (IIEF) [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886402


Locations
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United States, North Carolina
David Matthews MD Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Cheryl Calebro    704-375-2955    CjCalebro@davidmatthewsmd.com   
Principal Investigator: David M Matthews, MD         
Sub-Investigator: Michael Carstens, MD         
Sponsors and Collaborators
GID BIO, Inc.
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Responsible Party: GID BIO, Inc.
ClinicalTrials.gov Identifier: NCT03886402    
Other Study ID Numbers: GIDED-01
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders