The Safety of Intra-parenchymal Wharton Jelly Mesenchymal Stem Cell Injection in the Treatment of Diabetic Nephropathy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
Wharton Jelly derived Mesenchymal stem cells will be injected in the renal parenchyma of patients with Diabetic Nephropathy
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Wharton Jelly Mesenchymal stem cells (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 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.
次要结局
- 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)
研究者
Sophia Al-Adwan
Clinical Co-ordinator
University of Jordan