Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephro… (NCT07396155) | Clinical Trial Compass
RecruitingPhase 1/2
Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
Indonesia10 participantsStarted 2026-07-01
Plain-language 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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events and Serious Adverse Events
Timeframe: From baseline up to 12 months post-injection