<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/NCT03288571</url>
  </required_header>
  <id_info>
    <org_study_id>DNJUCTC</org_study_id>
    <nct_id>NCT03288571</nct_id>
  </id_info>
  <brief_title>Use of Wharton Jelly in Diabetic Nephropathy</brief_title>
  <official_title>The Safety of Intra-parenchymal Wharton Jelly Mesenchymal Stem Cell Injection in the Treatment of Diabetic Nephropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sophia Al-Adwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jordan University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>An-Najah National University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Wharton Jelly derived Mesenchymal stem cells will be injected in the renal parenchyma of&#xD;
      patients with Diabetic Nephropathy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mesenchymal stem cells (MSCs) are to be isolated from Umbilical cord Wharton's Jelly obtained&#xD;
      after normal full term delivery.&#xD;
&#xD;
      Samples will be tested for any bacterial or fungal growth as well as endotoxin and&#xD;
      mycoplasma. The specific markers for MSCs identification will be analyzed by flow cytometry.&#xD;
&#xD;
      Cell suspension will then be injected in the renal parenchyma of patients diagnosed with&#xD;
      diabetic nephropathy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2019</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>6 months</time_frame>
    <description>Number, frequency and severity of injection associated adverse events.&#xD;
The nephrologist will record any adverse event at each follow up visit in addition to evaluation of the overall condition of the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate</measure>
    <time_frame>12 months</time_frame>
    <description>• Any positive changes in the patient's kidney function in terms of Estimated Gomerular filtration rate (mL/min/1.73 m²)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the preliminary efficacy of the injection on kidney's protein to creatinine ratio</measure>
    <time_frame>12 months</time_frame>
    <description>Any positive changes in the patient's kidney function in terms of Urine protein to creatinine ratio.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Diabetic Nephropathies</condition>
  <arm_group>
    <arm_group_label>Wharton Jelly Mesenchymal stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Wharton Jelly Mesenchymal stem cells Site: Renal parenchyma Route of administration: ultrasound guided- intra-parenchymal total of 3 sites in each kidney.&#xD;
Number of doses: 3 doses 2 weeks apart for each kidney. Time interval between each dose: 2 weeks Total volume of cell suspension infused: 3 ml/kidney; each site will receive a 1 ml cell suspension with a total volume of 3 ml in each kidney.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Wharton Jelly Mesenchymal stem cells</intervention_name>
    <description>Wharton Jelly Mesenchymal stem cells will be injected in the renal parenchyma</description>
    <arm_group_label>Wharton Jelly Mesenchymal stem cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent.&#xD;
&#xD;
          -  Type 2 diabetes mellitus (DM) for ≥ 3 years.&#xD;
&#xD;
          -  Estimated GFR (eGFR) 15-45 ml/min/1.73 m2 by the Chronic Kidney Disease Epidemiology&#xD;
             Collaboration (CKD-EPI) equation on 2 or more consecutive measurements at least 30&#xD;
             days apart within the past 6 months, confirmed by isotope kidney scan.&#xD;
&#xD;
          -  Urine protein-to-creatinine ratio (UPCR) ≥ 500 mg/mmol (in spot urine or in 24 hour&#xD;
             urine collection) confirmed twice over a period of 6 months.&#xD;
&#xD;
          -  Ultrasonographic kidney measurements ≥ 10 cm (for both kidneys).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with uncontrolled hyper or hypo tension; (systolic pressure &gt;160, &lt;100:&#xD;
             diastolic pressure &lt; 60, &gt;100) on two different occasions.&#xD;
&#xD;
          -  Poor diabetic control: Hemoglobin A1c (HbA1c) &gt; 10%.&#xD;
&#xD;
          -  New use of hypoglycemic, antihypertensive and/or lipid lowering agent within the past&#xD;
             6 months.&#xD;
&#xD;
          -  Increase in the dose of anti-hypertensive and/or hypoglycemic agent of the previous&#xD;
             dose within the past 3 months.&#xD;
&#xD;
          -  Current fasting total cholesterol &gt;300 mg/dl.&#xD;
&#xD;
          -  Current fasting total triglycerides &gt;400 mg/dl.&#xD;
&#xD;
          -  History of any cardiovascular events in the past 6 months.&#xD;
&#xD;
          -  Pregnancy or lactating.&#xD;
&#xD;
          -  Positive screening test for infectious diseases as per baseline work up.&#xD;
&#xD;
          -  History of kidney transplant&#xD;
&#xD;
          -  Systemic autoimmune disease.&#xD;
&#xD;
          -  Receiving immunosuppressant medications.&#xD;
&#xD;
          -  Patients with glomerulonephritis or any non-DM related kidney disease.&#xD;
&#xD;
          -  Patients with any coagulation disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 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>
  <overall_contact>
    <last_name>Sofia Adwan, Msc</last_name>
    <phone>00962796175617</phone>
    <email>sophia.adwan@gmail.com</email>
  </overall_contact>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 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>Clinical Co-ordinator</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>nephropathy</keyword>
  <keyword>Kidney</keyword>
  <keyword>parenchyma</keyword>
  <keyword>Wharton Jelly</keyword>
  <keyword>Mesenchymal stem cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Diabetic Nephropathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>within one month of publication</ipd_time_frame>
  </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/NCT03288571
org study id: DNJUCTC
nct id: NCT03288571
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Wharton Jelly derived Mesenchymal stem cells will be injected in the renal parenchyma of
      patients with Diabetic Nephropathy
Mesenchymal stem cells (MSCs) are to be isolated from Umbilical cord Wharton's Jelly obtained
      after normal full term delivery.

      Samples will be tested for any bacterial or fungal growth as well as endotoxin and
      mycoplasma. The specific markers for MSCs identification will be analyzed by flow cytometry.

      Cell suspension will then be injected in the renal parenchyma of patients diagnosed with
      diabetic nephropathy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 6 months
description: Number, frequency and severity of injection associated adverse events.
The nephrologist will record any adverse event at each follow up visit in addition to evaluation of the overall condition of the patient.
measure: Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate
time frame: 12 months
description: • Any positive changes in the patient's kidney function in terms of Estimated Gomerular filtration rate (mL/min/1.73 m²)
measure: Evaluation of the preliminary efficacy of the injection on kidney's protein to creatinine ratio
time frame: 12 months
description: Any positive changes in the patient's kidney function in terms of Urine protein to creatinine ratio.
arm group label: Wharton Jelly Mesenchymal stem cells
arm group type: Experimental
description: Intervention: Wharton Jelly Mesenchymal stem cells Site: Renal parenchyma Route of administration: ultrasound guided- intra-parenchymal total of 3 sites in each kidney.
Number of doses: 3 doses 2 weeks apart for each kidney. Time interval between each dose: 2 weeks Total volume of cell suspension infused: 3 ml/kidney; each site will receive a 1 ml cell suspension with a total volume of 3 ml in each kidney.
intervention type: Biological
intervention name: Wharton Jelly Mesenchymal stem cells
description: Wharton Jelly Mesenchymal stem cells will be injected in the renal parenchyma
arm group label: Wharton Jelly Mesenchymal stem cells
criteria: 
gender: All
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: No
last name: Abdalla Awidi, MD
role: Study Director
affiliation: Cell Therapy Center
last name: Sofia Adwan, Msc
phone: 00962796175617
email: sophia.adwan@gmail.com
responsible party type: Sponsor-Investigator
investigator affiliation: University of Jordan
investigator full name: Sophia Al-Adwan
investigator title: Clinical Co-ordinator
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: within one month of publication