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Trial record 5 of 63 for:    Recruiting, Not yet recruiting, Available Studies | Impotence

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. Identifier: NCT03886402
Recruitment Status : Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : August 21, 2019
Information provided by (Responsible Party):
The GID Group

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
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 : November 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 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.

Information from the National Library of Medicine

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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

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

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Responsible Party: The GID Group Identifier: NCT03886402     History of Changes
Other Study ID Numbers: GIDED-01
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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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
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders