Status:
COMPLETED
Efficacy of Wharton Jelly in Erectile Dysfunction
Lead Sponsor:
Sophia Al-Adwan
Conditions:
Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Eligibility:
MALE
25-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Efficacy of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.
Detailed Description
This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which 22 male patients ranging from 25-70 years diagnosed with erectile dysfunction will be selected. This diagnosis is based ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Current or previous malignancy.
- Use of any non study treatment for erectile function within 4 weeks of study treatment.
- Lack of willingness to continue through 6 months after study treatment.
- Any previous penile implant or penile vascular surgery.
- Uncontrolled hypertension or hypotension(systolic blood pressure \> 170 or \< 90 mm Hg, and diastolic blood pressure \> 100 or \< 50 mm Hg).
- Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening.
- Bleeding or clotting disorder, use of anticoagulant therapy.
- Lab values for complete blood count (CBC), prothrombin time (PT)/ partial thromboplastin time (PTT)/ international normalized ratio (INR), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine falling outside the normal lab values.
- Systemic autoimmune disorder.
- Significant active systemic or localized infection.
- Receiving immunosuppressant medications.
- Post-radical prostatectomy.
Key Trial Info
Start Date :
January 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2019
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03751735
Start Date
January 27 2017
End Date
February 26 2019
Last Update
April 10 2019
Active Locations (1)
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1
Cell Therapy Center
Amman, Jordan, 11942