Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease

Inclusion criteria

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• Men and women who are ≥18 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, or the urine albumin-to-creatinine ratio (UACR) > 1000 mg/g.
• The estimated glomerular filtration rate (eGFR) ≥ 15 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.

Exclusion criteria

• Patients with kidney diseases not caused by diabetes mellitus.
• Patients who have received treatment with systemic immunosuppressants (such as cyclosporine A, tacrolimus, mycophenolate mofetil, etc.) within 30 days before enrollment and the duration of treatment exceeds one week.
• Severe cardiovascular diseases, such as congenital heart diseases, atrial fibrillation, NYHA class Ⅲ-IV, unstable angina pectoris, etc.
• A history of cerebral hemorrhage or cerebral infarction within the past six months (except for those with a history of lacunar cerebral infarction without residual limb movement disorders, cognitive and language function disorders).
• Patients with severe hyperlipidemia: (serum triglyceride ≥ 6.2 mmol/L, serum low-density lipoprotein cholesterol ≥ 4.1 mmol/L).
• Hyperkalemia that cannot be controlled through diet or potassium-lowering treatment.
• Patients with active infections of hepatitis B or hepatitis C viruses (the copy number of HBV DNA or HCV RNA exceeds the upper limit of the normal value); patients with active tuberculosis; patients with severe immunodeficiency diseases, human immunodeficiency virus (HIV) infection, etc.
• Patients with a history of malignant tumors within the past five years.
• Patients with a known history of severe allergy to component blood or blood products, or patients with a history of allergy to heterologous proteins.
• Lactating women, or female patients who have a pregnancy plan or an egg donation plan from the start of the study to the follow-up period, and male patients (or their partners) who have a childbearing plan or a sperm donation plan from the start of the study to the follow-up period and are unwilling to take contraceptive measures.
• Active infection within one week before enrollment and requiring treatment with intravenous antibiotics.
• Patients who have participated in other interventional clinical trials within three months before enrollment.
• The research physician deems that the patient's condition is not suitable for participating in this clinical study.