NCT07396155RecruitingPhase 1/2
Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Diseases
- Chronic kidney disease
- NCT number
- NCT07396155
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 10
- From 1 Jul 2026 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving immunosuppressive therapy equivalent to ≥20 mg/day prednisone
Other illness
- 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
Lab values
- 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
Age
- Positive pregnancy test or currently breastfeeding (for women of reproductive age)
Who the study is looking for
- 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
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Sardjito General Hospital Coordinator of this site? Confirm its status | Yogyakarta | Indonesia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.