Safety of Wharton Jelly in Erectile Dysfunction

Erectile Dysfunction Associated With Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945449
• Other study ID #: WJ.EDUJCTC
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2017
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Erectile Dysfunction
• Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Intervention

Biological:
• Wharton Jelly Mesenchymal stem cells
Intracavernous injection of Wharton Jelly Mesenchymal stem cells.

Locations

Country	Name	City	State
Jordan	Cell Therapy Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Sophia Al-Adwan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Patients will be assessed for any relevant adverse event resulting from the intracavernous injection of the Wharton jelly mesenchymal stem cells.	6 months
Secondary	Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaire	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.	12 months