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| Name | Class |
|---|---|
| Jordan University of Science and Technology | OTHER |
| An-Najah National University | OTHER |
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Wharton Jelly derived Mesenchymal stem cells will be injected in the renal parenchyma of patients with Diabetic Nephropathy
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wharton Jelly Mesenchymal stem cells | Biological | Wharton Jelly Mesenchymal stem cells will be injected in the renal parenchyma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Evaluation of the preliminary efficacy of the injection on kidney's protein to creatinine ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofia Adwan, Msc | Contact | 00962796175617 | sophia.adwan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Abdalla Awidi, MD | Cell Therapy Center | Study Director |
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within one month of publication
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003920 | Diabetes Mellitus |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Any positive changes in the patient's kidney function in terms of Urine protein to creatinine ratio. |
| 12 months |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |