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Efficacy of Wharton Jelly in Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03751735
Recruitment Status : Completed
First Posted : November 22, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sophia Al-Adwan, University of Jordan

Brief Summary:
Efficacy 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 Phase 2

Detailed Description:

This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which 22 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.

The investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy for Two Doses of Intracavernous Injection of Wharton Jelly Stem Cells for the Treatment of Diabetic Erectile Dysfunction
Actual Study Start Date : January 27, 2017
Actual Primary Completion Date : January 13, 2019
Actual Study Completion Date : February 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose 1
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. Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by Penile Doppler ultrasonography. [ Time Frame: 12 months ]
    Patients will be evaluated for the efficacy of the intracavernous injection of Wharton Jelly derived Mesenchymal Stem Cells by Penile Doppler ultrasonography in which peak systolic velocity of the cavernosal arteries will be measured.

  2. Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaires [ Time Frame: 12 months ]
    The efficacy of the intracavernous injection of Wharton Jelly will be evaluated by scoring the SHIM/IIEF/EHS questionnaires.



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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): NCT03751735


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

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Responsible Party: Sophia Al-Adwan, Researcher, Clinical coordinator, University of Jordan
ClinicalTrials.gov Identifier: NCT03751735     History of Changes
Other Study ID Numbers: WJEF.EDUJCTC
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sophia Al-Adwan, University of Jordan:
Diabetes
Wharton jelly mesenchymal stem cells
efficacy

Additional relevant MeSH terms:
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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