Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
NCT ID: NCT02945462
Last Updated: 2016-11-16
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
4 participants
INTERVENTIONAL
2013-09-30
2016-10-31
Brief Summary
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Detailed Description
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This study was performed:
1. To test the safety of autologous intracavernous bone marrow mesenchymal stem cells.
2. To evaluate benefit for the patient concerning recovery of natural erection by performing detailed and specific diagnostic tests prior and post MSCs injection by a team from Jordan University Hospital and Cell Therapy Center in Jordan University.
3. To study the feasibility, indication criteria and application modalities of Bone marrow mesenchymal stem cells for further wider study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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autologous mesenchymal stem cells
Intervention:
Autologous bone marrow derived stem cells will be injected twice intracavernously to enrolled erectile dysfunction patients
autologous mesenchymal stem cells
Patients will be injected with autologous mesenchymal stem cells, intracavernously
Interventions
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autologous mesenchymal stem cells
Patients will be injected with autologous mesenchymal stem cells, intracavernously
Eligibility Criteria
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Inclusion Criteria
2. Type 1 or type 2 diabetic patients with a personal history of diabetes ≥ 5 years.
3. History of chronic erectile dysfunction for at least six months.
4. HbA1c ≤ 10%.
5. Baseline International Index of Erectile Function (IIEF) score of \< 26.
6. Not interested or able to use Phosphodiesterase type 5 inhibitor (PDE-5i) drug therapy and willing to forgo these treatments for the first 6 month period following study treatment.
7. Body mass index between 20 -30.
8. 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. Current urinary tract or bladder infection.
3. Any medical evidence of any infectious disease.
4. Clinically evident penile anatomical deformities (e.g., Peyronie's disease) or history of priapism.
5. Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
6. Current or previous malignancy.
7. Patients with primary hyperlipidemia.
8. Use of any non study treatment for erectile dysfunction within 4 weeks of study treatment.
9. Lack of willingness to continue through 6 months after study treatment.
10. Any previous penile implant or penile vascular surgery.
11. Uncontrolled hypertension or hypotension (systolic blood pressure \> 170 or \< 90 mm Hg, and diastolic blood pressure \> 100 or \< 50 mm Hg).
12. 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.
13. Bleeding or clotting disorder, use of anticoagulant therapy.
14. Lab values for complete blood count, prothrombin time/ partial thromboplastin time/international randomized ratio (PT/PTT/INR), Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine falling outside the normal lab values.
15. Systemic autoimmune disorder.
16. Significant active systemic or localized infection.
17. Receiving immunosuppressant medications.
18. HbA1c \> 10%.
25 Years
65 Years
MALE
No
Sponsors
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University of Jordan
OTHER
Responsible Party
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Saddam Dmour
Researcher
References
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Al Demour S, Adwan S, Jafar H, Alhawari H, Awidi A. Stem cell therapy in diabetic men with erectile dysfunction: a 24-month follow-up of safety and efficacy of two intracavernous autologous bone marrow derived mesenchymal stem cells injections, an open label phase 2 clinical trial. Basic Clin Androl. 2024 Jul 5;34(1):13. doi: 10.1186/s12610-024-00229-y.
Other Identifiers
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EDUJCTC
Identifier Type: -
Identifier Source: org_study_id