Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
Recruiting · NCT07396155 · Interventional (participants receive a specific treatment) · Lead sponsor: PT. Prodia Stem Cell Indonesia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Who can take part
Inclusion criteria
- 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
- Presence of proteinuria, with urine albumin-to-creatinine ratio (UACR) between 30-3000 mg/g (spot morning urine sample)
- Controlled diabetes, defined as HbA1c \<10.0% during screening
- Blood pressure within the range of: Systolic 100-160 mmHg, Diastolic 60-100 mmHg
- On stable standard therapy for diabetic nephropathy (e.g. ACE inhibitors or ARBs) for at least 12 weeks prior to screening
- Willing to provide written informed consent and comply with all study procedures until completion
Exclusion criteria
- 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
- Positive pregnancy test or currently breastfeeding (for women of reproductive age)
- Currently receiving immunosuppressive therapy equivalent to ≥20 mg/day prednisone
- History of participation in other stem cell research or therapy studies
Where it is running
1 location listed.
- Dr. Sardjito General Hospital - Yogyakarta, Indonesia