CClinicalTrials.gg
Sign In
Status unknownNCT03288571Updated Jul 24, 2019

Use of Wharton Jelly in Diabetic Nephropathy

A Phase 1/2 interventional study of Wharton Jelly Mesenchymal stem cells in Diabetic Nephropathies, sponsored by Sophia Al-Adwan. Status unknown. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-24.

Sponsored by Sophia Al-Adwan · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
35 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Diabetic Nephropathies

Keywords

  • Diabetes
  • nephropathy
  • Kidney
  • parenchyma
  • Wharton Jelly
  • Mesenchymal stem cells
03

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Wharton Jelly Mesenchymal stem cells

    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

  • BiologicalWharton Jelly Mesenchymal stem cells

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

05

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. 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)

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03288571
Lead sponsor
Sophia Al-Adwan
Collaborators
Jordan University of Science and Technology, An-Najah National University
Responsible party
Sophia Al-Adwan (Clinical Co-ordinator, University of Jordan) — Sponsor-investigator
First posted
Sep 20, 2017
Start date
Nov 2019 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Jan 2021 (estimated)
Last update
Jul 24, 2019

Study contacts

Sofia Adwan, Msc
Contact
sophia.adwan@gmail.com
00962796175617
Abdalla Awidi, MD
study director · Cell Therapy Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Kidney Diseases→

Other studies from this sponsor

Sophia Al-Adwan

Start the discussion