Use of Wharton Jelly in Diabetic Nephropathy

The Safety of Intra-parenchymal Wharton Jelly Mesenchymal Stem Cell Injection in the Treatment of Diabetic Nephropathy

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

Study Overview

• Status: Unknown
• Conditions: Diabetic Nephropathies
• Intervention / Treatment: Biological: Wharton Jelly Mesenchymal stem cells

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Sophia Al-Adwan
• Collaborators: Jordan University of Science and Technology; An-Najah National University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; nephropathy; Kidney; parenchyma; Wharton Jelly; Mesenchymal stem cells
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: DNJUCTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: within one month of publication
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

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