Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2017-01-27
2019-02-26
Brief Summary
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Detailed Description
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The patients are followed by clinical assessment, laboratory investigations as well as Doppler ultrasound.
The investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose 1
Dose I of Wharton Jelly Mesenchymal stem cells (WJ-MSC) Two intracavernous injections of 20 million of WJ-MSC cells will be given to erectile dysfunction patients at baseline and 4th week of follow up
Wharton Jelly Mesenchymal stem cells
Intracavernous injection of Wharton Jelly Mesenchymal stem cells.
Interventions
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Wharton Jelly Mesenchymal stem cells
Intracavernous injection of Wharton Jelly Mesenchymal stem cells.
Eligibility Criteria
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Inclusion Criteria
2. History of chronic erectile dysfunction for at least six months.
3. Baseline international index of erectile function (IIEF) score of \< 26.
4. 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.
5. Body Mass Index between 20-30.
6. 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
2. Clinical/Laboratory evidence of transmissible diseases.
3. Clinically evident penile anatomical deformities(e.g., Peyronie's disease) or history of priapism.
4. Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
5. Current or previous malignancy.
6. Use of any non study treatment for erectile function within 4 weeks of study treatment.
7. Lack of willingness to continue through 6 months after study treatment.
8. Any previous penile implant or penile vascular surgery.
9. Uncontrolled hypertension or hypotension(systolic blood pressure \> 170 or \< 90 mm Hg, and diastolic blood pressure \> 100 or \< 50 mm Hg).
10. 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.
11. Bleeding or clotting disorder, use of anticoagulant therapy.
12. 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.
13. Systemic autoimmune disorder.
14. Significant active systemic or localized infection.
15. Receiving immunosuppressant medications.
16. Post-radical prostatectomy.
25 Years
70 Years
MALE
No
Sponsors
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Sophia Al-Adwan
OTHER
Responsible Party
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Sophia Al-Adwan
Researcher, Clinical coordinator
Principal Investigators
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Abdalla Awidi, MD
Role: STUDY_DIRECTOR
Cell Therapy Center
Locations
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Cell Therapy Center
Amman, , Jordan
Countries
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Other Identifiers
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WJEF.EDUJCTC
Identifier Type: -
Identifier Source: org_study_id
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