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 ≥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.
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).
Single group
Amimestrocel
DrugIn the first month (day 1, 14, 28): 1×10\^6 cells per kilogram. From the 8th to the 24th week (week 8, 12, 16, 20, 24): 1.5×10\^6 cells per kilogram.
Urine protein
Urine protein will be measured on 24h urine samples
estimated Glomerular Filtration Rate(eGFR)
GFR will be estimated by CKD-EPI
fasting blood glucose
fasting blood glucose
HbA1c
Glycated Hemoglobin A1c
Urinary Albumin/Creatinine Ratio(UACR)
UACR will be measured on spot morning urine samples
proportion of outcome ( ≥50% declined in eGFR，reached end stage renal disease (ESRD), or occured Renal replacement)
proportion of outcome ( ≥50% declined in eGFR，reached End Stage Renal Disease (ESRD), or occured Renal Replacement Therapy)
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