Erectile Dysfunction
Conditions
Brief summary
Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.
Detailed description
Four diabetic male patients ranging from 25-65 years diagnosed with erectile dysfunction will be selected. This diagnosis is based on medical history, validated questionnaires, physical examinations, laboratory tests and specific diagnostic tests. Patients with any evidence of untreated hypogonadism, current urinary tract or bladder infection, clinically evident penile anatomical deformities, previous penile implant or penile vascular surgery, uncontrolled hypertension or hypotension, reported unstable Cardiovascular diseases, uncontrolled diabetes (HbA1c \> 10%), or primary hyperlipidemia will be excluded. The investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients. 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.
Interventions
BIOLOGICALautologous mesenchymal stem cells
Patients will be injected with autologous mesenchymal stem cells, intracavernously
Sponsors
University of Jordan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult male patients ranging from 25 to 65 years. 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
1. Untreated hypogonadism or low serum total testosterone \< 200 ng/dl. 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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | six months | Observation of any relevant adverse side effect resulting from the injection. Assessing the safety of autologous Mesenchymal Stem Cells injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment the efficacy of intracavernous injection measured by SHIM/IIEF/EHS questionnaire | 18 months | Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Sexual Health Inventory for Men/ International Index for Erectile Function/ Erection Hardness Score (SHIM/IIEF/EHS) questionnaire. For every patient tests would be performed at baseline and repeated at 1,3, 6,12, and 18 months post-injection. |
| Evaluation the efficacy of intracavernous injection measured by Dynamic Infusion cavernosometry test. | 6 months | Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Dynamic Infusion Cavernosometry test at baseline and repeated at 6 months post injection. |
Outcome results
None listed