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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Diagnosed with Type 2 Diabetes Mellitus (T2DM)
Aged between 40 and 65 years
Diagnosed with chronic kidney disease (CKD) stage III or IV, defined as estimated GFR (eGFR) between 15-60 mL/min/1.73 m² (using CKD-EPI formula)
Renal biopsy showing diabetic nephropathy type IIa-IV
Active malignancy or history of cancer
Active liver disease or abnormal liver function (ALT or AST ≥2× upper limit of normal)
Hemoglobin <8 g/dL or platelet count <100,000/µL
Serious or unstable cerebrovascular or cardiovascular conditions within the last 6 months
PT. Prodia Stem Cell Indonesia
Lead sponsor
Dr. Sardjito General Hospital, Yogyakarta, Indonesia
Collaborator