Use of Wharton Jelly in Diabetic Nephropathy
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|ClinicalTrials.gov Identifier: NCT03288571|
Recruitment Status : Not yet recruiting
First Posted : September 20, 2017
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathies||Biological: Wharton Jelly Mesenchymal stem cells||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety of Intra-parenchymal Wharton Jelly Mesenchymal Stem Cell Injection in the Treatment of Diabetic Nephropathy|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
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
Wharton Jelly Mesenchymal stem cells will be injected in the renal parenchyma
- 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.
- Evaluation of the preliminary efficacy of the injection on kidney's Estimated Glomerular filtration rate [ Time Frame: 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 [ Time Frame: 12 months ]Any positive changes in the patient's kidney function in terms of Urine protein to creatinine ratio.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288571
|Contact: Sofia Adwan, Mscfirstname.lastname@example.org|
|Study Director:||Abdalla Awidi, MD||Cell Therapy Center|