Amimestrocel (umbilical cord mesenchymal stromal cells) for diabetic kidney disease

Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cell (Amimestrocel ) in Patients With Diabetic Kidney Disease

This trial will test whether umbilical cord-derived mesenchymal stromal cells (Amimestrocel) can improve kidney function or reduce protein in adults with progressive diabetic kidney disease.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Locations: 6 sites (Beijing, Beijing Municipality and 5 other locations)
• Trial ID: NCT06969807 on ClinicalTrials.gov

What this trial studies

This phase 2 interventional trial administers umbilical cord-derived mesenchymal stromal cells (Amimestrocel) to adults with biopsy-confirmed diabetic kidney disease and follows them for changes in renal function, proteinuria, and safety. Eligible participants are 18–80 years old with type 2 diabetes, heavy proteinuria (24‑hour ≥3.5 g or UACR >1000 mg/g), and eGFR ≥15 ml/min/1.73 m². Key exclusions include non-diabetic kidney disease, recent systemic immunosuppression, and severe cardiovascular disease. The trial is run at multiple major hospitals in Beijing and tracks both efficacy endpoints and adverse events over the follow-up period.

Who should consider this trial

Good fit: Adults aged 18–80 with type 2 diabetes, biopsy-confirmed diabetic kidney disease, heavy proteinuria (≥3.5 g/24 h or UACR >1000 mg/g), eGFR ≥15 ml/min/1.73 m², HbA1c <9%, and controllable blood pressure are ideal candidates.

Not a fit: Patients with kidney disease from other causes, recent systemic immunosuppressant use, severe cardiovascular disease, or very advanced renal failure below the eGFR cutoff are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, Amimestrocel could reduce proteinuria and slow decline in kidney function, potentially delaying the need for dialysis.

How similar studies have performed: Small early-phase trials of mesenchymal stromal cells in chronic kidney disease, including DKD, have reported acceptable safety and mixed signals of modest benefit on proteinuria, so the approach is promising but remains experimental.

Eligibility criteria

Inclusion Criteria: -

1. Men and women who are ≥18 and ≤ 80 years old.
2. Diagnosed with type 2 diabetes mellitus.
3. Diagnosed with diabetic kidney disease based on renal pathology within the past 10 years.
4. The 24-hour urine protein quantification is continuously ≥ 3.5 g, or the urine albumin-to-creatinine ratio (UACR) \> 1000 mg/g.
5. The estimated glomerular filtration rate (eGFR) ≥ 15 ml/min/1.73m² (calculated according to the CKD-EPI formula).
6. The blood pressure can be controlled at BP ≤ 160/100 mmHg.
7. Glycated hemoglobin (HbA1c) \< 9%.
8. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Patients with kidney diseases not caused by diabetes mellitus.
2. Patients who have received treatment with systemic immunosuppressants (such as cyclosporine A, tacrolimus, mycophenolate mofetil, etc.) within 30 days before enrollment and the duration of treatment exceeds one week.
3. Severe cardiovascular diseases, such as congenital heart diseases, atrial fibrillation, NYHA class Ⅲ-IV, unstable angina pectoris, etc.
4. A history of cerebral hemorrhage or cerebral infarction within the past six months (except for those with a history of lacunar cerebral infarction without residual limb movement disorders, cognitive and language function disorders).
5. Patients with severe hyperlipidemia: (serum triglyceride ≥ 6.2 mmol/L, serum low-density lipoprotein cholesterol ≥ 4.1 mmol/L).
6. Hyperkalemia that cannot be controlled through diet or potassium-lowering treatment.
7. Patients with active infections of hepatitis B or hepatitis C viruses (the copy number of HBV DNA or HCV RNA exceeds the upper limit of the normal value); patients with active tuberculosis; patients with severe immunodeficiency diseases, human immunodeficiency virus (HIV) infection, etc.
8. Patients with a history of malignant tumors within the past five years.
9. Patients with a known history of severe allergy to component blood or blood products, or patients with a history of allergy to heterologous proteins.
10. Lactating women, or female patients who have a pregnancy plan or an egg donation plan from the start of the study to the follow-up period, and male patients (or their partners) who have a childbearing plan or a sperm donation plan from the start of the study to the follow-up period and are unwilling to take contraceptive measures.
11. Active infection within one week before enrollment and requiring treatment with intravenous antibiotics.
12. Patients who have participated in other interventional clinical trials within three months before enrollment.
13. The research physician deems that the patient's condition is not suitable for participating in this clinical study.

Where this trial is running

Beijing, Beijing Municipality and 5 other locations

• Beijing Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Capital Medical University Affiliated Beijing Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: xiangmei chen

Conditions: Diabetic Kidney Disease, mesenchymal stromal cells, Diabetic kidney disease