Acute kidney injury
Conditions
Interventions
Dose level1:Human amniotic epithelial stem cell injection(hAESCs)
Dose:1×10^6 cells/kg
hAESCs injection was given intravenously only once after enrollment.
Dose level 2:Human amniotic epithelial stem cell injection(hAESCs)
Dose:2×10^6 cells/kg
Dose level3:Human amniotic epithelial stem cell injection(hAESCs)
Dose:3×10^6 cells/kg
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years old; 2) Indwelling urinary catheter in ICU; 3) Patients who meet the AKI criteria and are classified as grade 3 after admission to the ICU. According to the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic criteria: AKI diagnosis: Serum creatinine increases by =0.3mg/dl (=26.5µmol/l) within 48 hours; or serum creatinine increases to =1.5 times the basic value, and it is clear or inferred that it occurred within the previous 7 days; or it persists Urine output in 6 hours <0.5ml/kg/h; AKI grade 3 criteria: Serum creatinine is 3.0 times the basic value; or serum creatinine increases to =4.0mg/dl (353.6µmol/L); or renal replacement therapy is started; or urine output is <0.3ml/kg/h, sustained =24h or anuria =12h. 4) Consistent with the cause of sepsis or hypovolemia. Diagnostic criteria for sepsis: According to the sepsis3.0 diagnostic criteria (consideration of infection and SOFA score = 2 points); if it meets the following causes or is judged by a clinician to be hypovolemia: absolute loss of intravascular volume (such as gastrointestinal fluid loss, Bleeding and dehydration, etc.); relative loss of intravascular volume, reduction of effective circulating blood volume (such as accumulation of third space fluid caused by peritonitis, acute pancreatitis, hepatorenal syndrome, etc.)
Exclusion criteria
Exclusion criteria: 1) Chronic kidney disease stage 4 and above [CKD-4, eGFR<30mL/min; CKD-5, eGFR<15mL/min. according CKD-EPI formula]; 2) Patients with arteriovenous fistula or long-term dialysis tube for long-term regular dialysis; 3) AKI grade 3 occurs before admission to ICU; 4) Kidney-related surgeries were performed after this admission, including nephrectomy, partial nephrectomy, kidney transplantation, renal vascular surgery, renal cyst removal, etc.; 5) Pregnancy (fertile woman need to undergo urine pregnancy test); 6) Allergy or history of drug allergy that may be life-threatening 7) Confirmed autoimmune disease or immunodeficiency disease; 8) Expected survival =72h; 9) Patients/relatives do not agree to enter the study; 10) Currently participating in other clinical trials; 11) Other situations where the doctor in charge deems it inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Tolerable dose of hAESCs injection;Adverse reaction;Acute infusion reaction;Incidence of ectopic mass associated with reagent infusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute Kidney Injury Scale Change (KDIGO scale);All-cause mortality;Renal replacement therapy ratio;Laboratory examination;Electrocardiogram;Vital sign;Maximum tolerated dose;Quality of Life (WHOQOL-Bref scale); | — |
Countries
China
Contacts
Public ContactYang LI
Peking University First Hospital
Outcome results
None listed