Diabetic Nephropathies
Conditions
Keywords
Diabetes, nephropathy, Kidney, parenchyma, Wharton Jelly, Mesenchymal stem cells
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.
Interventions
BIOLOGICALWharton Jelly Mesenchymal stem cells
Wharton Jelly Mesenchymal stem cells will be injected in the renal parenchyma
Sponsors
Jordan University of Science and Technology
An-Najah National University
Sophia Al-Adwan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate | 12 months | • 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 | 12 months | Any positive changes in the patient's kidney function in terms of Urine protein to creatinine ratio. |
Contacts
Primary ContactSofia Adwan, Msc
Outcome results
None listed