Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cell (Amimestrocel ) in Patients With Diabetic Kidney Disease
This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD patients.
• Men and women who are ≥ 45 and ≤ 80 years old.
• Diagnosed with type 2 diabetes mellitus.
• Diagnosed with diabetic kidney disease based on renal pathology within the past 10 years.
• The 24-hour urine protein quantification is continuously ≥ 3.5 g, and the urine albumin-to-creatinine ratio (UACR) \> 1000 mg/g.
• The estimated glomerular filtration rate (eGFR) ≥ 20 ml/min/1.73m² (calculated according to the CKD-EPI formula).
• The blood pressure can be controlled at BP ≤ 160/100 mmHg.
• Glycated hemoglobin (HbA1c) \< 9%.
• Willing and able to provide written informed consent.