Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
Key facts
- Where
- Yogyakarta, IndonesiaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 65 years old?
Source: NCT07396155, who can take part
Where in Indonesia
- Dr. Sardjito General HospitalYogyakarta, IndonesiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- PT. Prodia Stem Cell Indonesia
- Trial code
- NCT07396155
- Record updated
- 9 February 2026
- Original description
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:Read full original descriptionShow less
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].
Inclusion: 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: Currently receiving immunosuppressive therapy equivalent to ≥20 mg/day prednisone; Active malignancy or history of cancer; Serious or unstable cerebrovascular or cardiovascular conditions within the last 6 months; History of participation in other stem cell research or therapy studies; 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; Positive pregnancy test or currently breastfeeding (for women of reproductive age).