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Clinical Trials/NCT03886402
NCT03886402
Withdrawn
Not Applicable

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

GID BIO, Inc.1 site in 1 country8 target enrollmentOctober 2021
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ConditionsErectile Dysfunction

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erectile Dysfunction
Sponsor
GID BIO, Inc.
Enrollment
8
Locations
1
Primary Endpoint
Adverse Events
Status
Withdrawn
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2021
End Date
October 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Adverse Events

Time Frame: 1 year

Monitoring of adverse events

Secondary Outcomes

  • International Index of Erectile Function (IIEF)(Pre-treatment, 30 days, 3 months and 6 months)

Study Sites (1)

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