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

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GID SVF-2
Sponsored by
GID BIO, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • David Matthews MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Each subject will receive a single injection of autologous adipose-derived stromal vascular fraction (SVF) and will be monitored for 6 months

Outcomes

Primary Outcome Measures

Adverse Events
Monitoring of adverse events

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2019
Last Updated
April 29, 2021
Sponsor
GID BIO, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03886402
Brief Title
Adipose-derived SVF for Treatment of Erectile Dysfunction (ED)
Official Title
Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Erectile Dysfunction - A Safety and Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GID BIO, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Each subject will receive a single injection of autologous adipose-derived stromal vascular fraction (SVF) and will be monitored for 6 months
Intervention Type
Device
Intervention Name(s)
GID SVF-2
Other Intervention Name(s)
GIDZyme-2-50, GID Procedure Pack
Intervention Description
Treatment of erectile dysfunction with the subjects own cells
Primary Outcome Measure Information:
Title
Adverse Events
Description
Monitoring of adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
International Index of Erectile Function (IIEF)
Description
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
Other Pre-specified Outcome Measures:
Title
Partner Satisfaction Questionnaire
Description
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.
Time Frame
Pre-treatment and 30 days, 3 months and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
David Matthews MD
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl Calebro
Phone
704-375-2955
Email
CjCalebro@davidmatthewsmd.com
First Name & Middle Initial & Last Name & Degree
David M Matthews, MD
First Name & Middle Initial & Last Name & Degree
Michael Carstens, MD

12. IPD Sharing Statement

Learn more about this trial

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

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