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

G

GID BIO

Status

Withdrawn

Conditions

Erectile Dysfunction

Treatments

Device: GID SVF-2

Study type

Interventional

Funder types

Industry

Identifiers

NCT03886402
GIDED-01

Details and patient eligibility

About

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

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Treatment
Experimental group
Description:
Each subject will receive a single injection of autologous adipose-derived stromal vascular fraction (SVF) and will be monitored for 6 months
Treatment:
Device: GID SVF-2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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