Diabetic NephropathiesPhase 1/2NCT03288571
Use of Wharton Jelly in Diabetic Nephropathy
A Phase 1/2 study testing Wharton Jelly Mesenchymal stem cells in people with Diabetic Nephropathies, run by Sophia Al-Adwan.
Trial summary
Wharton Jelly derived Mesenchymal stem cells will be injected in the renal parenchyma of patients with Diabetic Nephropathy Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Wharton Jelly Mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Jan 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Safety of Intra-parenchymal Wharton Jelly Mesenchymal Stem Cell Injection in the Treatment of Diabetic Nephropathy
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.
- Conditions
- Diabetic Nephropathies
- Being tested
- Wharton Jelly Mesenchymal stem cells
- Keywords
- Diabetes, nephropathy, Kidney, parenchyma, Wharton Jelly, Mesenchymal stem cells
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wharton Jelly Mesenchymal stem cellsBiological
Wharton Jelly Mesenchymal stem cells will be injected in the renal parenchyma
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Wharton Jelly Mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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)
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study startNov 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophia Al-Adwan
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology, An-Najah National University
- Responsible party
- Sponsor-investigator, Sophia Al-Adwan, University of Jordan
- Investigators
- Abdalla Awidi, MD, Study director, Cell Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288571
- Sponsor's protocol ID
- DNJUCTC
- Status last verified
- Jul 2019
- First submitted
- 8 Aug 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Intra-parenchymal Wharton Jelly Mesenchymal Stem Cell Injection in the Treatment of Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT03288571
- Acronym / sponsor ID
- DNJUCTC
- Conditions
- Diabetic Nephropathies
- Keywords
- Diabetes, nephropathy, Kidney, parenchyma, Wharton Jelly, Mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sophia Al-AdwanUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology, An-Najah National University
- Study start
- Nov 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wharton Jelly Mesenchymal stem cells | Experimental | Biological: Wharton Jelly Mesenchymal stem cellsIntervention: 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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wharton Jelly Mesenchymal stem cellsWharton Jelly Mesenchymal stem cells will be injected in the renal parenchyma | Biological | Wharton Jelly Mesenchymal stem cells |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 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.
2 secondary outcomes
Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate
Time frame: 12 months
Evaluation of the preliminary efficacy of the injection on kidney's protein to creatinine ratio
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdalla Awidi, MD study director
Cell Therapy Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Wharton Jelly Mesenchymal stem cells in people with Diabetic Nephropathies, run by Sophia Al-Adwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofia Adwan, Msc (00962796175617, sophia.adwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.