RecruitingPhase 1Phase 2NCT07396155

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


Sponsor

PT. Prodia Stem Cell Indonesia

Enrollment

10 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].


Eligibility

Min Age: 30 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether stem cells from donated umbilical cord tissue can slow or reverse kidney damage caused by Type 2 diabetes — a condition called diabetic nephropathy. Researchers hope that these donated stem cells, delivered by infusion, can repair the kidneys and reduce protein leakage into the urine. **You may be eligible if...** - You are between 40 and 65 years old - You have been diagnosed with Type 2 diabetes - You have moderate-to-severe chronic kidney disease (CKD Stage 3 or 4, with a filtration rate between 15 and 60) - A kidney biopsy has confirmed diabetic nephropathy - You have protein in your urine at a specific level **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are on dialysis or have had a kidney transplant - You have certain autoimmune diseases, active infections, or other serious illnesses - You are currently taking immunosuppressant medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUmbilical Cord Mesenchymal Stem Cells

This 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.


Locations(1)

Dr. Sardjito General Hospital

Yogyakarta, Indonesia

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NCT07396155


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