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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)

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ClinicalTrials.gov Identifier: NCT03886402
Recruitment Status : Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : August 21, 2019
Sponsor:
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.



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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

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Responsible Party: The GID Group
ClinicalTrials.gov 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