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