Clinical trial NCT03288571: Use of Wharton Jelly in Diabetic Nephropathy
Official title: The Safety of Intra-parenchymal Wharton Jelly Mesenchymal Stem Cell Injection in the Treatment of Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Nephropathies
Keywords: Diabetes
nephropathy
Kidney
parenchyma
Wharton Jelly
Mesenchymal stem cells
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
name: An-Najah National University
First posted: 2017-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate
timeFrame: 12 months
measure: Evaluation of the preliminary efficacy of the injection on kidney's protein to creatinine ratio
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Cell Therapy Center
name: Abdalla Awidi, MD
role: STUDY_DIRECTOR
References: