Evaluating Safety and Benefits of Umbilical Cord Stem Cell Injection for Adults with Diabetic Nephropathy Aged 40 to 65

What this Trial Is About

Researchers are evaluating the safety and potential benefits of a single injection of allogeneic umbilical cord-derived mesenchymal stem cells UC-MSCs in adults aged 40 to 65 years with diabetic nephropathy, a kidney disease caused by diabetes. This study aims to find out if UC-MSC therapy is safe and well-tolerated when given directly into the kidneys and whether it can improve kidney function and reduce inflammation over a 12-month period. The trial is an open-label, single-arm study designed to explore these effects in patients who have chronic kidney disease stages III or IV related to diabetes. Participants will receive one intra-renal injection of UC-MSCs at a dose of 1 x 106 cells per kilogram of body weight. After the injection, they will be monitored over 12 months with scheduled visits at 1, 3, 6, 9, and 12 months to assess kidney function and inflammation. The treatment is given under imaging guidance to ensure accurate delivery. This trial does not include a comparison group and focuses on changes from baseline measurements following the intervention. During the study, participants will undergo evaluations of kidney function through estimated glomerular filtration rate eGFR, serum creatinine levels, and urine albumin-to-creatinine ratio. Inflammatory markers such as TNF-alpha and IL-10 will also be measured. Safety will be closely monitored by tracking any adverse events throughout the 12-month follow-up. The studys main outcome is to record the incidence of adverse events, with secondary outcomes focusing on changes in kidney function and inflammation markers over time.

Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial