Health Trials

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

ConditionsErectile DysfunctionErectile Dysfunction Associated With Type 2 Diabetes MellitusErectile Dysfunction Due to Arterial DiseaseErectile Dysfunction Due to Arterial InsufficiencyErectile Dysfunction Due to General Medical ConditionErectile Dysfunction Due to Neuropathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-70
SponsorLabbafinejad Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • exosomes derived from human umbilical cord mesenchymal stem cells
  • Normal (0.9%) saline

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Labbafinejad Medical Center

Lead sponsor

Source ClinicalTrials.gov