Amimestrocel (umbilical cord mesenchymal stromal cells) for 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: liping.8@163.com
• Phone: +86 010 66935462

Similar studies

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

• Goal-Directed Heart, Kidney, and Metabolic Care to Help Adults with Diabetic Kidney Disease

  This trial tests a structured, early CKM care plan alongside usual care to see if it is feasible and safe for adults with type 2 diabetes and diabetic kidney disease who are at high cardiovascular risk.

  Recruiting Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT07434791

• ANGPTL3 inhibition for adults with diabetic kidney disease

  This study tests whether two drugs that block ANGPTL3, ALN-ANG3 and evinacumab, are safe and help adults with type 2 diabetes who have diabetic kidney disease.

  Recruiting at 57 sites Phase 2 Regeneron Pharmaceuticals · Huntsville, Alabama and 58 other locations · NCT07271186

• Isuzinaxib for adults with diabetic kidney disease

  This trial tests whether isuzinaxib (APX-115) is safe and can reduce protein in the urine and protect kidneys in adults with type 2 diabetes and diabetic kidney disease.

  Recruiting at 17 sites Phase 2 Aptabio Therapeutics, Inc. · Ansan-si and 19 other locations · NCT06962098

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.