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

Erectile Dysfunction Clinical Trial

Official title:

Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Erectile Dysfunction - A Safety and Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03886402
• Other study ID #: GIDED-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: October 2022

Study information

• Verified date: April 2021
• Source: GID BIO, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• GID SVF-2
Treatment of erectile dysfunction with the subjects own cells

Locations

Country	Name	City	State
United States	David Matthews MD	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GID BIO, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Partner Satisfaction Questionnaire	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.	Pre-treatment and 30 days, 3 months and 6 months
Primary	Adverse Events	Monitoring of adverse events	1 year
Secondary	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	Pre-treatment, 30 days, 3 months and 6 months