A Phase 2 interventional study of exosomes derived from human umbilical cord mesenchymal stem cells and Normal (0.9%) saline in Erectile Dysfunction, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus and Erectile Dysfunction Due to Arterial Disease, sponsored by Labbafinejad Medical Center. Not yet recruiting at 1 site in Iran. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Labbafinejad Medical Center · Phase 2, Interventional, and Treatment
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:
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
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 70 is close to the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →This is the only study on the registry with Labbafinejad Medical Center as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Moderate or severe erectile dysfunction (according to IIEF-5) Non-satisfactory response to other treatments Generally Healthy males Not having severe past medical history
Exclusion Criteria:
Known allergy or history of hyperactivity to biological substances Peyronie's plaque Existing medical condition (severe or uncontrolled) Use of psychiatric medication Use of thyroid medication Hyopgonadism Hypergonadism Cancer History of prostatectomy Prostitis disease Recent trauma or surgery Ongoing systemic infection Skin lesion or infection at the site of injection
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients in this arm 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: exosomes derived from human umbilical cord mesenchymal stem cells
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.
Biological: Normal (0.9%) saline
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.
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
Plan to share: Undecided — It is not yet known if there will be a plan to make this available.
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