Use of Wharton Jelly in Diabetic Nephropathy

Sophia Al-Adwan

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Diabetic Nephropathies

Treatments: Biological: Wharton Jelly Mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03288571

DNJUCTC

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Wharton Jelly Mesenchymal stem cells

Experimental group

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.

Treatment:

Biological: Wharton Jelly Mesenchymal stem cells