Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)

Phase 1

Completed

• Conditions: Erectile Dysfunction
• Interventions: Biological: autologous mesenchymal stem cells

• Registration Number: NCT02945462
• Lead Sponsor: University of Jordan

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.

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2015-11
• Study Completion: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous mesenchymal stem cells	autologous mesenchymal stem cells	Intervention: Autologous bone marrow derived stem cells will be injected twice intracavernously to enrolled erectile dysfunction patients

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.