Diabetic nephropathy (DN) is a chronic kidney disease caused by diabetes. It is one of the most common and most serious microvascular complications of diabetes. Current treatment options for DN are limited. Mesenchymal stem cells (MSCs) are considered one of the promising treatments for DN. This study aims to evaluate the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with type 2 DN.
Aged 18 to 80 years, with no gender and ethnicity restrictions.
Baseline serum C-peptide concentrations ranging from 0.3 to 3.0 ng/mL;
Stable antihyperglycemic and antihypertensive medication regimen for at least 3 months prior to screening, defined as dosage adjustment less than 25%.
Urinary albumin-to-creatinine ratio (UACR) ≥ 30 and ≤ 5000 mg/g together with estimated glomerular filtration rate (eGFR) ≥ 30 and < 90 mL/min/1.73 m².
Other non-T2DM, such as type 1 diabetes.
Individuals allergic to MSCs or their preservation solution.
History of acute diabetic complications within the past 6 months, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis;
Unstable disease status or severe diabetic complications within the past 6 months, such as proliferative diabetic retinopathy or macular edema, severe diabetic neuropathy, intermittent claudication, active diabetic foot lesions;