Umbilical cord stem cell injection into the kidney for people with diabetic kidney disease.
Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
This trial will try a single intra-renal injection of umbilical cord–derived mesenchymal stem cells to see if it is safe and helps adults aged 40–65 with diabetic nephropathy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | PT. Prodia Stem Cell Indonesia Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 1 site (Yogyakarta) |
| Trial ID | NCT07396155 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, open-label Phase 1/2 prospective trial enrolling adults 40–65 with type 2 diabetic nephropathy and CKD stage III–IV. Each participant receives one intra-renal injection of allogeneic umbilical cord–derived mesenchymal stem cells at 1 × 10⁶ cells/kg and is followed for 12 months with visits at 1, 3, 6, 9, and 12 months. The study measures renal function (eGFR, serum creatinine, urine albumin-creatinine ratio), inflammatory biomarkers (TNF-α, IL-10), and safety outcomes including adverse events. The primary goal is to gather early human safety data and signals of biological activity for this delivery approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40–65 with type 2 diabetes, biopsy-proven diabetic nephropathy, CKD stage III–IV (eGFR 15–60 mL/min/1.73 m²), proteinuria (UACR 30–3000 mg/g), controlled HbA1c (<10%), and on stable ACE inhibitor or ARB therapy.
Not a fit: Patients with active cancer, significant liver disease, severe anemia or thrombocytopenia, uncontrolled diabetes, end-stage renal disease outside the eGFR range, or inability to attend follow-up visits are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this therapy could slow kidney function decline and reduce inflammation in people with diabetic nephropathy, potentially delaying progression to end-stage kidney disease.
How similar studies have performed: Mesenchymal stem cell therapies have shown promising anti-inflammatory and renal effects in preclinical work and early-phase clinical studies, but intra-renal delivery of allogeneic umbilical cord MSCs remains experimental and not yet proven in larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Yogyakarta
- Dr. Sardjito General Hospital — Yogyakarta, Indonesia (Recruiting)
Study contacts
- Study coordinator: Metalia Puspitasari, MD
- Email: puspitasarimetalia@gmail.com
- Phone: +628116110283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.