Safety of Wharton Jelly in Erectile Dysfunction

• Sponsor: Sophia Al-Adwan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02945449
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Actual Duration (Months): 21.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Safety of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Associated With Type 2 Diabetes Mellitus	Biological: Wharton Jelly Mesenchymal stem cells	Phase 1

Detailed Description

This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which nine male patients ranging from 25-70 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.

The patients are followed by clinical assessment, laboratory investigations as well as Doppler ultrasound.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase Ib: Evaluation of the Safety and as a Secondary End Point the Efficacy for Two Doses of Wharton Jelly Stem Cells for the Treatment of Diabetic Erectile Dysfunction
• Actual Study Start Date: Jan 4, 2017
• Actual Primary Completion Date: Oct 15, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose I 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.	Biological: Wharton Jelly Mesenchymal stem cells; Intracavernous injection of Wharton Jelly Mesenchymal stem cells.

Outcome Measures

Primary Outcome Measures

1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [6 months]

   Patients will be assessed for any relevant adverse event resulting from the intracavernous injection of the Wharton jelly mesenchymal stem cells.

Secondary Outcome Measures

1. Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaire [12 months]

   Patients will be evaluated for the efficacy of the intracavernous injection of Wharton Jelly derived Mesenchymal Stem Cells by Sexual Health Inventory for Men/International Index of Erectile Function/Erection Hardness Score (SHIM/IIEF/EHS) questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult male patients ranging from 25 to 70 years.

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:

1. Current urinary tract or bladder infection.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cell Therapy Center	Amman		Jordan	11942

Sponsors and Collaborators

• Sophia Al-Adwan

Investigators

• Study Director: Abdallah Awidi, MD, Cell Therapy Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sophia Al-Adwan, Researcher, Msc, University of Jordan
• ClinicalTrials.gov Identifier: NCT02945449
• Other Study ID Numbers: WJ.EDUJCTC
• First Posted: Oct 26, 2016
• Last Update Posted: Nov 15, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Sophia Al-Adwan, Researcher, Msc, University of Jordan: Wharton jelly mesenchymal stem cells; Erectile Dysfunction; Diabetes; safety
• Additional relevant MeSH terms: Erectile Dysfunction; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 15, 2018