NCT04194671Unknown1 期
A Single-center, Randomized, Placebo-controlled, Patient-blinded Study of Mesenchymal Stem Cells Therapy in Subjects With Severe Acute Kidney Injury Receiving Routine Therapy
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年12月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The difference in the renal function between the two groups (MSC treatment group vs placebo control group) within 28 days after receiving MSC/ placebo treatment
研究概览
简要总结
Acute kidney injury(AKI) is a common, severe emergency case in clinics,especially severe AKI ,which is associated with higher morbidity and mortality. Effect of routine therapy is limited and mesenchymal stem cells (MSC)are considered a new therapy for treating severe acute kidney injury. Patients will be randomized to receive intravenous infusion of MSC, or placebo control. This trial is to investigate whether MSC can improve renal recovery and mortality of patients with AKI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have severe AKI defined as more than two-fold increase serum creatinine level compared with baseline within 48 hours and/or urinary output consistently<0.5 ml/kg/h over 12 hours
- •Age between 18 and 65 years
- •Willing or having a legally acceptable representative to give a written informed consent
- •Able to comply with visit schedule and study procedures including post-hospitalization discharge follow-up
排除标准
- •AKI due to post-renal outflow obstruction,glomerulonephritis,lupus nephritis, antineutrophil cytoplasmic antibody (ANCA) related nephritis, antiglomerular basement membrane disease, cryoglobulinemia, thrombotic microangiopathy, and AKI caused by purpura nephritis
- •Pregnant or lactating woman
- •Allergic person
- •Organ transplant or hematopoietic stem cell transplant
- •Patients with malignant tumors or those with a history of cancer
- •Life expectancy is less than 3 months
- •Known end-stage liver disease
- •Uncontrollable infection
- •Patients younger than 65 years old ,whose estimated glomerular filtration rate (eGFR) were less than 60
- •Severe pulmonary dysfunction
- •Severe cardiac dysfunction,left ventricular ejection fraction is less than 40%, or severe arrhythmia patients
- •Hemodynamically unstable patients
- •Organ failure affecting more than 2 non-renal organs
- •Acute or chronic vasculitis of any cause
- •History of chronic systemic infection of any cause
- •The investigators believe that subjects may need to gradually increase the dose of vasopressor to achieve and / or maintain hemodynamic stability
- •Systemic immunosuppressive therapy that has not been stabilized for greater than 4 months, or in the case of chronic corticosteroid therapy, a dose of >15 mg/day of prednisone or the equivalent within the past 30 days
- •Platelet count <25,000/uL or other severe hematologic abnormalities, causing the subject to be at risk of death
- •Patients need mechanical ventilation
- •Participate in other clinical trials
研究组 & 干预措施
Mesenchymal stem cells cohort
Experimental
干预措施: Mesenchymal stem cells (Biological)
结局指标
主要结局
The difference in the renal function between the two groups (MSC treatment group vs placebo control group) within 28 days after receiving MSC/ placebo treatment
时间窗: within 28 days after receiving MSC/ placebo treatment
Compare the creatinine concentration between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.
次要结局
- Overall survival within 28 days after receiving MSC/ placebo treatment(28 days)
- Renal replacement therapy (RRT) dependent within 3 months after receiving MSC/ placebo treatment(3 months)
- Adverse events within 3 months after receiving MSC/ placebo treatment(3 months)
- Complete renal recovery within 3 months after receiving MSC/ placebo treatment(3 months)
- Partial renal recovery within 3 months after receiving MSC/ placebo treatment(3 months)
- Overall survival within 3 months after receiving MSC/ placebo treatment(3 months)
- ICU and hospitalization duration of stay among all AKI patients within 3 months after receiving MSC/ placebo treatment(3 months)
研究者
Chen Xiangmei
Principal Investigator
Chinese PLA General Hospital
研究点 (1)
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