Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury
Trial Parameters
Brief Summary
This trial is to evaluate the efficacy and safety of Amimestrocel (human umbilical cord mesenchymal stromal cells) in the treatment of AKI patients.
Eligibility Criteria
Inclusion Criteria: 1. Aged between 18 and 75 years old; gender is not restricted. 2. According to the 2023 KDIGO diagnostic criteria for acute kidney injury (AKI), including those that occur during the course of the disease in various patients with chronic kidney disease (CKD), AKI can be diagnosed if any of the following conditions is met: ① The serum creatinine level increases by ≥ 26.5 μmol/L within 48 hours; ② The serum creatinine level increases by more than 1.5 times or higher than the baseline value within 7 days; ③ The urine output decreases (\< 0.5 mL/kg/h) and persists for more than 6 hours; The baseline value of serum creatinine: The lowest creatinine value obtained in the outpatient department or ward within 3 months, and the longest time limit is the creatinine value within 1 year. If there is no such value, the serum creatinine can be estimated using the MDRD equation under the assumption that the baseline eGFR is 75 ml/min/1.73m². 3. .Ability to give informed consent. E