Safety of Wharton Jelly in Erectile Dysfunction

November 13, 2018 updated by: Sophia Al-Adwan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11942
        • Cell Therapy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sophia Al-Adwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2017

Primary Completion (Actual)

October 15, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WJ.EDUJCTC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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