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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
In experimental group, patients receive standard treatment and allogeneic human umbilical cord derived-mesenchymal stem cells (MSCs) is administered via intravenous infusion on day 0 and day 7
In placebo control group, patients receive standard treatment and saline is administered via intravenous infusion on day 0 and day 7
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
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
Compare the creatinine concentration between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.
Time frame: within 28 days after receiving MSC/ placebo treatment
Overall survival within 28 days after receiving MSC/ placebo treatment
Compare the overall survival rate between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.
Time frame: 28 days
Overall survival within 3 months after receiving MSC/ placebo treatment
Compare the overall survival rate between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/ placebo treatment.
Time frame: 3 months
Renal replacement therapy (RRT) dependent within 3 months after receiving MSC/ placebo treatment
Compare the rate of renal replacement therapy (RRT) dependence between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/ placebo treatment.
Time frame: 3 months
Complete renal recovery within 3 months after receiving MSC/ placebo treatment
Compare the rate of complete renal recovery between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment. We considered complete recovery as alive, free of RRT, and the SCR decreased to no more than 1.5 times of the baseline level.
Time frame: 3 months
Partial renal recovery within 3 months after receiving MSC/ placebo treatment
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Compare the rate of partial renal recovery between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment. Partial recovery refers to survival, free of RRT, and the SCR 1.5 times higher than the baseline level of creatinine.
Time frame: 3 months
ICU and hospitalization duration of stay among all AKI patients within 3 months after receiving MSC/ placebo treatment
Compare the days in ICU and hospital between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment.
Time frame: 3 months
Adverse events within 3 months after receiving MSC/ placebo treatment
Compare the rate of adverse events between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment.
Time frame: 3 months