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.
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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
Single group
Umbilical Cord Mesenchymal Stem Cells
Biological/VaccineThis intervention consists of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) administered under imaging guidance. The dose administered is 1 × 10⁶ cells per kilogram of body weight.
Incidence of Adverse Events and Serious Adverse Events
Safety is assessed by recording the number and percentage of participants experiencing any adverse events (AEs), including both local and systemic reactions.
Change in Estimated Glomerular Filtration Rate (eGFR)
Calculated using the CKD-EPI 2021 formula
Change in Serum Creatinine
Measured in mg/dL. Collected via venous blood samples
Change in Urine Albumin-to-Creatinine Ratio (UACR)
Measured in mg/g from morning spot urine samples
Change in Serum TNF-α Levels
Tumor necrosis factor-alpha (TNF-α) is measured in patient serum using ELISA as a marker of systemic inflammation. The change in TNF-α concentration from baseline over 12 months will be analyzed to evaluate the immunomodulatory effect of UC-MSC therapy.
Change in Serum IL-10 Levels
Interleukin-10 (IL-10) is measured in patient serum using ELISA as an anti-inflammatory cytokine. This outcome assesses whether UC-MSC treatment modulates IL-10 levels over a 12-month follow-up period.
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PT. Prodia Stem Cell Indonesia
Lead sponsor
Dr. Sardjito General Hospital, Yogyakarta, Indonesia
Collaborator
