Efficacy of Wharton Jelly in Erectile Dysfunction (NCT03751735) | Clinical Trial Compass
CompletedPhase 1/2
Efficacy of Wharton Jelly in Erectile Dysfunction
Jordan9 participantsStarted 2017-01-27
Plain-language summary
Efficacy of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.
Who can participate
Age range
25 Years – 70 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult male patients ranging from 25 to 70 years.
. History of chronic erectile dysfunction for at least six months.
. Baseline international index of erectile function (IIEF) score of \< 26.
. Not interested or able to use phosphodiesterase type 5 inhibitor (PD5i) drug therapy and willing to forgo theses treatments for the first 6 month period following study treatment.
. Body Mass Index between 20-30.
. Willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol.
Exclusion criteria
. Current urinary tract or bladder infection.
. Clinical/Laboratory evidence of transmissible diseases.
. Clinically evident penile anatomical deformities(e.g., Peyronie's disease) or history of priapism.
. Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by Penile Doppler ultrasonography.
Timeframe: 12 months
2
Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaires