Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease (NCT06969807) | Clinical Trial Compass
RecruitingPhase 2
Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease
China120 participantsStarted 2025-06-09
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.