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Use of Wharton Jelly in Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathies

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Wharton Jelly Mesenchymal stem cells
Sponsored by
Sophia Al-Adwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathies focused on measuring Diabetes, nephropathy, Kidney, parenchyma, Wharton Jelly, Mesenchymal stem cells

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Type 2 diabetes mellitus (DM) for ≥ 3 years.
  • Estimated GFR (eGFR) 15-45 ml/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation on 2 or more consecutive measurements at least 30 days apart within the past 6 months, confirmed by isotope kidney scan.
  • Urine protein-to-creatinine ratio (UPCR) ≥ 500 mg/mmol (in spot urine or in 24 hour urine collection) confirmed twice over a period of 6 months.
  • Ultrasonographic kidney measurements ≥ 10 cm (for both kidneys).

Exclusion Criteria:

  • Patients with uncontrolled hyper or hypo tension; (systolic pressure >160, <100: diastolic pressure < 60, >100) on two different occasions.
  • Poor diabetic control: Hemoglobin A1c (HbA1c) > 10%.
  • New use of hypoglycemic, antihypertensive and/or lipid lowering agent within the past 6 months.
  • Increase in the dose of anti-hypertensive and/or hypoglycemic agent of the previous dose within the past 3 months.
  • Current fasting total cholesterol >300 mg/dl.
  • Current fasting total triglycerides >400 mg/dl.
  • History of any cardiovascular events in the past 6 months.
  • Pregnancy or lactating.
  • Positive screening test for infectious diseases as per baseline work up.
  • History of kidney transplant
  • Systemic autoimmune disease.
  • Receiving immunosuppressant medications.
  • Patients with glomerulonephritis or any non-DM related kidney disease.
  • Patients with any coagulation disorder.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Wharton Jelly Mesenchymal stem cells

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
    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.

    Secondary Outcome Measures

    Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate
    • Any positive changes in the patient's kidney function in terms of Estimated Gomerular filtration rate (mL/min/1.73 m²)
    Evaluation of the preliminary efficacy of the injection on kidney's protein to creatinine ratio
    Any positive changes in the patient's kidney function in terms of Urine protein to creatinine ratio.

    Full Information

    First Posted
    August 8, 2017
    Last Updated
    July 23, 2019
    Sponsor
    Sophia Al-Adwan
    Collaborators
    Jordan University of Science and Technology, An-Najah National University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03288571
    Brief Title
    Use of Wharton Jelly in Diabetic Nephropathy
    Official Title
    The Safety of Intra-parenchymal Wharton Jelly Mesenchymal Stem Cell Injection in the Treatment of Diabetic Nephropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2019 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    January 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Sophia Al-Adwan
    Collaborators
    Jordan University of Science and Technology, An-Najah National University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Wharton Jelly derived Mesenchymal stem cells will be injected in the renal parenchyma of patients with Diabetic Nephropathy
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Nephropathies
    Keywords
    Diabetes, nephropathy, Kidney, parenchyma, Wharton Jelly, Mesenchymal stem cells

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Wharton Jelly Mesenchymal stem cells
    Arm Type
    Experimental
    Arm 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(s)
    Wharton Jelly Mesenchymal stem cells
    Intervention Description
    Wharton Jelly Mesenchymal stem cells will be injected in the renal parenchyma
    Primary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate
    Description
    • Any positive changes in the patient's kidney function in terms of Estimated Gomerular filtration rate (mL/min/1.73 m²)
    Time Frame
    12 months
    Title
    Evaluation of the preliminary efficacy of the injection on kidney's protein to creatinine ratio
    Description
    Any positive changes in the patient's kidney function in terms of Urine protein to creatinine ratio.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Willing and able to provide written informed consent. Type 2 diabetes mellitus (DM) for ≥ 3 years. Estimated GFR (eGFR) 15-45 ml/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation on 2 or more consecutive measurements at least 30 days apart within the past 6 months, confirmed by isotope kidney scan. Urine protein-to-creatinine ratio (UPCR) ≥ 500 mg/mmol (in spot urine or in 24 hour urine collection) confirmed twice over a period of 6 months. Ultrasonographic kidney measurements ≥ 10 cm (for both kidneys). Exclusion Criteria: Patients with uncontrolled hyper or hypo tension; (systolic pressure >160, <100: diastolic pressure < 60, >100) on two different occasions. Poor diabetic control: Hemoglobin A1c (HbA1c) > 10%. New use of hypoglycemic, antihypertensive and/or lipid lowering agent within the past 6 months. Increase in the dose of anti-hypertensive and/or hypoglycemic agent of the previous dose within the past 3 months. Current fasting total cholesterol >300 mg/dl. Current fasting total triglycerides >400 mg/dl. History of any cardiovascular events in the past 6 months. Pregnancy or lactating. Positive screening test for infectious diseases as per baseline work up. History of kidney transplant Systemic autoimmune disease. Receiving immunosuppressant medications. Patients with glomerulonephritis or any non-DM related kidney disease. Patients with any coagulation disorder.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sofia Adwan, Msc
    Phone
    00962796175617
    Email
    sophia.adwan@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abdalla Awidi, MD
    Organizational Affiliation
    Cell Therapy Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    within one month of publication

    Learn more about this trial

    Use of Wharton Jelly in Diabetic Nephropathy

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