Trial studying safety and effects for Diabetic Nephropathy Type 2
Official title Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
ClinicalTrials.gov ID: NCT07396155
What this study is testing
What is Umbilical Cord Mesenchymal Stem Cells?
Umbilical Cord Mesenchymal Stem Cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetic nephropathy type 2.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if the stem‑cell injection is safe and whether it can improve kidney function and reduce inflammation over a year.
- Who it's for
- Adults aged 40 to 65 who have type‑2 diabetic nephropathy.
- What's involved
- Participants receive a single injection of stem cells into the kidney, then attend clinic visits at 1, 3, 6, 9 and 12 months for blood and urine tests and safety checks.
- Time commitment
- The trial lasts 12 months with five follow‑up visits after the initial injection.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 65
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Yogyakarta, Indonesia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Yogyakarta, Indonesia. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.