NCT07396155 Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
| NCT ID | NCT07396155 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | PT. Prodia Stem Cell Indonesia |
| Condition | Diabetic Nephropathy Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2026-07-01 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07396155 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 65 Years, studying Diabetic Nephropathy Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07396155 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07396155 currently recruiting?
Yes, NCT07396155 is actively recruiting participants. Contact the research team at puspitasarimetalia@gmail.com for enrollment information.
Where is the NCT07396155 trial being conducted?
This trial is being conducted at Yogyakarta, Indonesia.
Who is sponsoring the NCT07396155 clinical trial?
NCT07396155 is sponsored by PT. Prodia Stem Cell Indonesia. The trial plans to enroll 10 participants.