A Randomized Controlled Study of Mesenchymal Stem Cells in the Treatment of Chronic Kidney Diseases
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
This study will evaluate the effect of intravenous injection of umbilical cord tissue derived mesenchymal stem cells (UMSCs) on the improvement of renal function in patients with chronic kidney disease (CKD) at stage 3 or 4, with the change of estimated glomerular filtration rate (eGFR) as the primary endpoint, and other changes in renal function laboratory indicators, changes in other organ system function laboratory indicators, and adverse reaction events as secondary endpoints. This trial aims to further evaluate the efficacy and safety of UMCSs in CKD patients, and provide new insights into expanding the clinical treatment strategies, delaying the progression and improving the prognosis of CKD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreement to participate in the trial and provision of signed written informed consent
- •Pathological diagnosis of diabetic nephropathy or hypertensive renal damage
- •15 ≤ eGFR < 60 mL/min/1.73m², UACR > 300 mg/g
- •Age ≥ 18 years
排除标准
- •Extremely severe anemia (hemoglobin < 30 g/L)
- •Received blood product transfusion therapy within 1 month
- •Autosomal dominant or recessive polycystic kidney disease (ADPKD)
- •History of kidney transplant or other solid organ transplant
- •Active systemic or localized infection (e.g., pneumonia, osteomyelitis)
- •Allergy to stem cells themselves or stem cell-related culture medium
- •History of allergic reaction to cell products (e.g., blood transfusion, platelets)
- •History of coagulation disorders (thromboembolism, pulmonary embolism, deep vein thrombosis)
- •History of malignancy or current malignant disease
- •Elevated tumor markers (AFP, CEA, CA199, CA125, etc.)
- •Pregnant women or women with plans for pregnancy within 3 months after MSC therapy
- •Participation in drug-related clinical trials within the past 2 months
- •Any form of drug abuse, mental illness, or other conditions considered by the investigator as potentially affecting the trial's validity or the subject's health
研究组 & 干预措施
DKD
干预措施: MSCs (Drug)
HN
干预措施: MSCs (Drug)
non-DKD
干预措施: 0.9% sodium chloride (Drug)
non-HN
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
Primary Outcome Measure
时间窗: From enrollment to the end of treatment at 12 months
Efficacy Endpoints: Changes in eGFR, 24-hour urine protein, and UACR at 1, 3, 6, and 12 months will serve as primary endpoints to assess renal function improvement. Changes in other renal function parameters (e.g., quantitative urine protein, urine red blood cells, serum creatinine, cystatin C),and changes in other organ system function parameters (e.g., ECG/echocardiography, complete blood count, liver function, NT-proBNP, parathyroid hormone, 25-dihydroxyvitamin D, lymphocyte subsets) at 1, 3, 6, and 12 months will serve as secondary endpoints.
次要结局
未报告次要终点
研究者
Li Jipeng
Principal Investigator
The First Affiliated Hospital of Air Force Medicial University