Umbilical cord stem cell injection into the kidney for people with diabetic kidney disease.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dr. Sardjito General Hospital
  Yogyakarta, Indonesia Recruiting

Study contacts

• Study coordinator: Metalia Puspitasari, MD
• Email: puspitasarimetalia@gmail.com
• Phone: +628116110283

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using a genetic test to manage heart and kidney complications in type 2 diabetes

  This study is testing if a genetic test can help doctors better manage heart and kidney problems in people with type 2 diabetes by personalizing their treatment based on their genetic risk.

  Recruiting Optithera · Montreal, Quebec and 1 other locations · NCT06586203

• New methods for diagnosing and treating type 2 diabetes nephropathy

  This study is testing new ways to diagnose and treat kidney problems in people with type 2 diabetes by using advanced tools and combining different medical approaches.

  Recruiting Chinese PLA General Hospital · Beijing · NCT05888909

• Identifying early markers for diabetic kidney disease using lipid analysis.

  This study is trying to find early signs of kidney damage in people with Type 2 diabetes by looking at fat levels in their blood and urine over several years.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou · NCT04931537

• Umbilical Cord Mesenchymal Stem Cells for Diabetic Kidney Disease

  This study tests whether injecting human umbilical cord mesenchymal stem cells can help people with diabetic nephropathy by reducing kidney inflammation and damage.

  Recruiting Phase 1 Tongji Hospital · Wuhan · NCT07822152

• Lactoferrin Supplement in Diabetic Kidney Disease

  Scientists test whether adding lactoferrin helps people with diabetic nephropathy who also have moderately to severely increased urinary albumin.

  Recruiting Phase 2 Ain Shams University · Cairo · NCT07764991

• A system for preventing and controlling diabetic nephropathy

  This study is trying to create a system to better understand and manage diabetic nephropathy by collecting data on risk factors and symptoms from a large group of people with diabetes.

  Recruiting Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT06843304

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.