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Use of Wharton Jelly in Diabetic Nephropathy

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ClinicalTrials.gov Identifier: NCT03288571
Recruitment Status : Not yet recruiting
First Posted : September 20, 2017
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
Jordan University of Science and Technology
An-Najah National University
Information provided by (Responsible Party):
Sophia Al-Adwan, University of Jordan

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

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Biological: Wharton Jelly Mesenchymal stem cells Phase 1 Phase 2

Detailed Description:

Mesenchymal stem cells 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety of Intra-parenchymal Wharton Jelly Mesenchymal Stem Cell Injection in the Treatment of Diabetic Nephropathy
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wharton Jelly Mesenchymal stem cells

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.

Biological: Wharton Jelly Mesenchymal stem cells
Wharton Jelly Mesenchymal stem cells will be injected in the renal parenchyma




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 6 months ]
    • 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 :
  1. Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate [ Time Frame: 12 months ]
    • Any positive changes in the patient's kidney function in terms of Estimated Gomerular filtration rate (mL/min/1.73 m²)

  2. Evaluation of the preliminary efficacy of the injection on kidney's protein to creatinine ratio [ Time Frame: 12 months ]
    Any positive changes in the patient's kidney function in terms of Urine protein to creatinine ratio.



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03288571


Contacts
Contact: Sofia Adwan, Msc 00962796175617 sophia.adwan@gmail.com

Sponsors and Collaborators
Sophia Al-Adwan
Jordan University of Science and Technology
An-Najah National University
Investigators
Study Director: Abdalla Awidi, MD Cell Therapy Center

Responsible Party: Sophia Al-Adwan, Clinical Co-ordinator, University of Jordan
ClinicalTrials.gov Identifier: NCT03288571     History of Changes
Other Study ID Numbers: DNJUCTC
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
nephropathy
Kidney
parenchyma
Wharton Jelly
Mesenchymal stem cells

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases