Use of Wharton Jelly in Diabetic Nephropathy

NCT03288571 | Unknown Phase 1 DMC

• 1 other identifier: DNJUCTC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Nephropathies

Keywords

Diabetes; nephropathy; Kidney; parenchyma; Wharton Jelly; Mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate

  12 months

• Evaluation of the preliminary efficacy of the injection on kidney's protein to creatinine ratio

  12 months

Study Arms (1)

Wharton Jelly Mesenchymal stem cells

EXPERIMENTAL

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

Interventions

Wharton Jelly Mesenchymal stem cells BIOLOGICAL

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

Wharton Jelly Mesenchymal stem cells

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sophia Al-Adwan: lead
• Jordan University of Science and Technology: collaborator
• An-Najah National University: collaborator

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Abdalla Awidi, MD

  Cell Therapy Center

  STUDY DIRECTOR

Central Study Contacts

Sofia Adwan, Msc

CONTACT

00962796175617; sophia.adwan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Co-ordinator

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: September 20, 2017
• Study Start: November 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: within one month of publication