Use of Wharton Jelly in Diabetic Nephropathy

Diabetic Nephropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03288571
• Other study ID #: DNJUCTC
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: November 2019
• Est. completion date: January 2021

Study information

• Verified date: July 2019
• Source: University of Jordan
• Contact: Sofia Adwan, Msc
• Phone: 00962796175617
• Email: sophia.adwan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sophia Al-Adwan	An-Najah National University, Jordan University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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