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Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction

NCT07319533 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-01-06

No results posted yet for this study

Summary

The goal of this clinical trial is to Investigate the Effect of Injection of MSC-Derived Exosome on Patients with Erectile Dysfunction in overall healthy males, aged 18-70, with-out any severe active medical condition, with moderate to severe erectile dysfunction based on IIEF-5, and non-satisfactory response to other treatments (5PDEI). The main question it aims to answer is:

• Is MSC-derived exosome safe and effective in treating patients with ED by improving IIEF-5 score?

If there is a comparison group: Researchers will compare the intervention group (Exosome receiving group) with control group (placebo receiving group) to see if exosomes are safe and effective in treating male adult patients with moderate-sever ED.

Participants will receive six weekly injections of normal saline or exosome (based on group), and will undergo necessarily follow up, and examinations and observation.

Conditions

  • Erectile Dysfunction
  • Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
  • Erectile Dysfunction Due to Arterial Disease
  • Erectile Dysfunction Due to Arterial Insufficiency
  • Erectile Dysfunction Due to General Medical Condition
  • Erectile Dysfunction Due to Neuropathy

Interventions

BIOLOGICAL

exosomes derived from human umbilical cord mesenchymal stem cells

Intervention group: patients in this group will be injected 5 ml of exosome in corpus cavernosa of each side (2.5 ml in each side at base of the penis). This will happen once a week, for 6 weeks. Inorder to prevent the injected substance from spreading systemically, a tourniquet will be placed at the base of the penis for 10 minute following injection.

BIOLOGICAL

Normal (0.9%) saline

Control group: these patients will recieve 5 ml of intracavernosal normal saline (2.5 ml in each side of penile base). This will happen once a week, for 6 weeks. Inorder to prevent the injected substance from spreading systemically, a tourniquet will be placed at the base of the penis for 10 minute following injection.

Sponsors & Collaborators

  • Labbafinejad Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07319533 on ClinicalTrials.gov