<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03751735</url>
  </required_header>
  <id_info>
    <org_study_id>WJEF.EDUJCTC</org_study_id>
    <nct_id>NCT03751735</nct_id>
  </id_info>
  <brief_title>Efficacy of Wharton Jelly in Erectile Dysfunction</brief_title>
  <official_title>Evaluation of the Efficacy for Two Doses of Intracavernous Injection of Wharton Jelly Stem Cells for the Treatment of Diabetic Erectile Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sophia Al-Adwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jordan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the&#xD;
      treatment of erectile dysfunction in diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which 22 male&#xD;
      patients ranging from 25-70 years diagnosed with erectile dysfunction will be selected. This&#xD;
      diagnosis is based on medical history, validated questionnaires, physical examinations,&#xD;
      laboratory tests and specific diagnostic tests.&#xD;
&#xD;
      The patients are followed by clinical assessment, laboratory investigations as well as&#xD;
      Doppler ultrasound.&#xD;
&#xD;
      The investigators hypothesize that the intracavernous injection of stem cells will facilitate&#xD;
      the recovery of erectile function resulting in satisfying clinical outcomes in patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Actual">February 26, 2019</completion_date>
  <primary_completion_date type="Actual">January 13, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by Penile Doppler ultrasonography.</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaires</measure>
    <time_frame>12 months</time_frame>
    <description>The efficacy of the intracavernous injection of Wharton Jelly will be evaluated by scoring the SHIM/IIEF/EHS questionnaires.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Erectile Dysfunction Associated With Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Wharton Jelly Mesenchymal stem cells</intervention_name>
    <description>Intracavernous injection of Wharton Jelly Mesenchymal stem cells.</description>
    <arm_group_label>Dose 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult male patients ranging from 25 to 70 years.&#xD;
&#xD;
          2. History of chronic erectile dysfunction for at least six months.&#xD;
&#xD;
          3. Baseline international index of erectile function (IIEF) score of &lt; 26.&#xD;
&#xD;
          4. Not interested or able to use phosphodiesterase type 5 inhibitor (PD5i) drug therapy&#xD;
             and willing to forgo theses treatments for the first 6 month period following study&#xD;
             treatment.&#xD;
&#xD;
          5. Body Mass Index between 20-30.&#xD;
&#xD;
          6. Willing to provide written informed consent, complete questionnaire, and to be&#xD;
             available for all baseline treatment and follow up examinations required by protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current urinary tract or bladder infection.&#xD;
&#xD;
          2. Clinical/Laboratory evidence of transmissible diseases.&#xD;
&#xD;
          3. Clinically evident penile anatomical deformities(e.g., Peyronie's disease) or history&#xD;
             of priapism.&#xD;
&#xD;
          4. Skin irritation, infection, wound, sore or disruption in the immediate areas of skin&#xD;
             entry for penile injection.&#xD;
&#xD;
          5. Current or previous malignancy.&#xD;
&#xD;
          6. Use of any non study treatment for erectile function within 4 weeks of study&#xD;
             treatment.&#xD;
&#xD;
          7. Lack of willingness to continue through 6 months after study treatment.&#xD;
&#xD;
          8. Any previous penile implant or penile vascular surgery.&#xD;
&#xD;
          9. Uncontrolled hypertension or hypotension(systolic blood pressure &gt; 170 or &lt; 90 mm Hg,&#xD;
             and diastolic blood pressure &gt; 100 or &lt; 50 mm Hg).&#xD;
&#xD;
         10. Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction&#xD;
             within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart&#xD;
             failure) or symptomatic postural hypotension within 6 months before screening.&#xD;
&#xD;
         11. Bleeding or clotting disorder, use of anticoagulant therapy.&#xD;
&#xD;
         12. Lab values for complete blood count (CBC), prothrombin time (PT)/ partial&#xD;
             thromboplastin time (PTT)/ international normalized ratio (INR), alanine&#xD;
             aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine falling&#xD;
             outside the normal lab values.&#xD;
&#xD;
         13. Systemic autoimmune disorder.&#xD;
&#xD;
         14. Significant active systemic or localized infection.&#xD;
&#xD;
         15. Receiving immunosuppressant medications.&#xD;
&#xD;
         16. Post-radical prostatectomy.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdalla Awidi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cell Therapy Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cell Therapy Center</name>
      <address>
        <city>Amman</city>
        <zip>11942</zip>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 9, 2019</last_update_submitted>
  <last_update_submitted_qc>April 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Jordan</investigator_affiliation>
    <investigator_full_name>Sophia Al-Adwan</investigator_full_name>
    <investigator_title>Researcher, Clinical coordinator</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Wharton jelly mesenchymal stem cells</keyword>
  <keyword>efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03751735
org study id: WJEF.EDUJCTC
nct id: NCT03751735
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Efficacy of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the
      treatment of erectile dysfunction in diabetic patients.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by Penile Doppler ultrasonography.
time frame: 12 months
description: 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.
measure: Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaires
time frame: 12 months
description: The efficacy of the intracavernous injection of Wharton Jelly will be evaluated by scoring the SHIM/IIEF/EHS questionnaires.
arm group label: Dose 1
arm group type: Experimental
description: 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
intervention type: Biological
intervention name: Wharton Jelly Mesenchymal stem cells
description: Intracavernous injection of Wharton Jelly Mesenchymal stem cells.
arm group label: Dose 1
criteria: 
gender: Male
gender based: Yes
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Abdalla Awidi, MD
role: Study Director
affiliation: Cell Therapy Center
facility: 
country: Jordan
responsible party type: Sponsor-Investigator
investigator affiliation: University of Jordan
investigator full name: Sophia Al-Adwan
investigator title: Researcher, Clinical coordinator
mesh term: Erectile Dysfunction
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided