Investigating the Effect of Exosome Derived From Human Fetal Umbilical Cord Mesanchymal Cells as Complimintary Treatment in Moderate to Severe Erectile Dysfunction
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Labbafinejad Medical Center
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- IIEF-5 score
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Intervention (Exosome)
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.
Intervention: exosomes derived from human umbilical cord mesenchymal stem cells (Biological)
Control
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.
Intervention: Normal (0.9%) saline (Biological)
Outcomes
Primary Outcomes
IIEF-5 score
Time Frame: 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 Outcomes
- Peak Systolic Voulme(week 0, 7, 13)
- EHS score(week 0, 7, 13, 25, 49)
- Side effects(week 1, 2, 3, 4, 5, 6)
- End Diastolic Volume(week 0, 7, 13)
- Pulled length of penis(week 0, 7, 13, 25, 49)
- Erected length of Penis(week 0, 7, 13, 25, 49)
Investigators
Amirhossein Kashi
Doctor Amirhossein Kashi
Labbafinejad Medical Center