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
Conditions
Keywords
Erectile Dysfunction, Exosome, Mesanchymal Stem Cell, MSC
Brief 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.
Detailed description
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
Interventions
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.
BIOLOGICALNormal (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
Labbafinejad Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A single blinded randomized clinical trail with a placebo-controlled group, consisting 70 patients in total (35 patients in each arm)
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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 Autoimmune disease Recent trauma or surgery Ongoing systemic infection Skin lesion or infection at the site of injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IIEF-5 score | week 0, 7, 13, 25, 49 | Erectile dysfunction of the patients during the study will be assessed by IIEF-5 questionnaire. It will done in a interview with the patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Systolic Voulme | week 0, 7, 13 | Peak systolic volum or arterial blood flow of the penis, which will be assessed by doppler sonography after papaverin injection |
| End Diastolic Volume | week 0, 7, 13 | end diastolic volume or venous blood flow of the penis which will be assessed by doppler sonography after papaverin injection |
| EHS score | week 0, 7, 13, 25, 49 | Erectile Hardness Score It will be done in a interview with the patients. |
| Erected length of Penis | week 0, 7, 13, 25, 49 | erected length of penis which will be assessed at follow up sessions by clinician |
| Side effects | week 1, 2, 3, 4, 5, 6 | any immeadiate, or late onset local side effects at injection site. these will be reported both by the patients and assessed by the clinician. |
| Pulled length of penis | week 0, 7, 13, 25, 49 | the pulled length of penis which will be assessed by clinician at each follow up session |
Countries
Iran
Outcome results
None listed