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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • exosomes derived from human umbilical cord mesenchymal stem cells

    Biological/Vaccine

    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.

  • Normal (0.9%) saline

    Biological/Vaccine

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Intervention (Exosome)Experimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

IIEF-5 score

Erectile dysfunction of the patients during the study will be assessed by IIEF-5 questionnaire. It will done in a interview with the patients.

Time frame
week 0, 7, 13, 25, 49

Secondary outcomes

1

EHS score

Erectile Hardness Score It will be done in a interview with the patients.

Time frame
week 0, 7, 13, 25, 49
2

Peak Systolic Voulme

Peak systolic volum or arterial blood flow of the penis, which will be assessed by doppler sonography after papaverin injection

Time frame
week 0, 7, 13
3

End Diastolic Volume

end diastolic volume or venous blood flow of the penis which will be assessed by doppler sonography after papaverin injection

Time frame
week 0, 7, 13
4

Pulled length of penis

the pulled length of penis which will be assessed by clinician at each follow up session

Time frame
week 0, 7, 13, 25, 49

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Labbafinejad Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: