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

Overview

The goal of this clinical trial is to evaluate the safety and efficacy of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in adults with diabetic nephropathy aged 40 to 65 years. The primary questions the study aims to answer are: 1. Is UC-MSC therapy safe and well-tolerated when administered intra-renally in patients with diabetic nephropathy? 2. Does UC-MSC therapy improve kidney function and modulate inflammatory markers over a 12-month follow-up-period? This is a single-arm, open-label, prospective clinical trial. Participants will receive a one-time intra-renal injection of UC-MSC at a dose of 1 x 10⁶ cells/kg body weight. Participants will attend scheduled follow-up visits at 1, 3, 6, 9, and 12 months post-injections for evaluation of: 1. Renal function (eGFR, serum creatinine, and urine albumin-creatinine ratio) 2. Inflammatory markers (TNF-α, IL-10) 3. Safety outcomes including early and late adverse events The results will be compared to baseline measurements to assess changes after the intervention. If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\]. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Diabetic nephropathy (DN) is one of the most common microvascular complications of diabetes mellitus and a leading cause of end-stage renal disease worldwide. Despite current standard therapies, many patients continue to experience progressive decline in renal function. As inflammation and immune dysregulation are increasingly recognized as contributors to DN pathogenesis, novel therapeutic strategies targeting these mechanisms are being explored. Mesenchymal stem cells (MSCs), particularly those derived from umbilical cord tissue, have shown promising anti-inflammatory and regenerative effects in preclinical studies of kidney disease. Their immunomodulatory properties, low immunogenicity, and ease of collection make them a compelling option for cell-based therapies. This clinical trial aims to evaluate the safety and potential therapeutic benefit of allogeneic umbilical cord-derived MSCs administered via intra-renal injection in individuals with diabetic nephropathy. The study is designed to provide early human data on the feasibility of using UC-MSCs as an adjunctive therapy in DN management. By assessing changes in renal function and inflammatory biomarkers over time, the trial seeks to explore the biological impact of UC-MSC therapy in this population. This research represents an important step toward developing cell-based interventions for chronic kidney disease, particularly in settings where conventional treatments are insufficient. The findings are expected to contribute valuable data to the growing field of regenerative nephrology.