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Safety of Wharton Jelly in Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT02945449
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sophia Al-Adwan, University of Jordan

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
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 : January 4, 2017
Actual Primary Completion Date : October 15, 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945449


Locations
Jordan
Cell Therapy Center
Amman, Jordan, 11942
Sponsors and Collaborators
Sophia Al-Adwan
Investigators
Study Director: Abdallah Awidi, MD Cell Therapy Center

Responsible Party: Sophia Al-Adwan, Researcher, Msc, University of Jordan
ClinicalTrials.gov Identifier: NCT02945449     History of Changes
Other Study ID Numbers: WJ.EDUJCTC
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
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, University of Jordan:
Wharton jelly mesenchymal stem cells
Erectile Dysfunction
Diabetes
safety

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Erectile Dysfunction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders