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.
Secondary outcomes are the folllowing: EHS score length of erected penis lenght of flacid penis (pulled) peak systolic volume (via dupler sonography) end diastolic volume (via dupler sonography) any adverse effects of exosome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
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.
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.
Shahid Labbafinejad Hospital
Tehran, Tehran Province, Iran
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
EHS score
Erectile Hardness Score It will be done in a interview with the patients.
Time frame: week 0, 7, 13, 25, 49
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
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
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
Erected length of Penis
erected length of penis which will be assessed at follow up sessions by clinician
Time frame: week 0, 7, 13, 25, 49
Side effects
any immeadiate, or late onset local side effects at injection site. these will be reported both by the patients and assessed by the clinician.
Time frame: week 1, 2, 3, 4, 5, 6
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