Status:
RECRUITING
Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Diabetic Kidney Disease (DKD)
Eligibility:
All Genders
45-80 years
Phase:
PHASE2
Brief Summary
This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate w...
Eligibility Criteria
Inclusion
- Men and women who are ≥ 45 and ≤ 80 years old.
- Diagnosed with type 2 diabetes mellitus.
- Diagnosed with diabetic kidney disease based on renal pathology within the past 10 years.
- The 24-hour urine protein quantification is continuously ≥ 3.5 g, and the urine albumin-to-creatinine ratio (UACR) \> 1000 mg/g.
- The estimated glomerular filtration rate (eGFR) ≥ 20 ml/min/1.73m² (calculated according to the CKD-EPI formula).
- The blood pressure can be controlled at BP ≤ 160/100 mmHg.
- Glycated hemoglobin (HbA1c) \< 9%.
- Willing and able to provide written informed consent.
Exclusion
- Patients with kidney diseases not caused by diabetes mellitus.
- 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.
- Severe cardiovascular diseases, such as congenital heart diseases, atrial fibrillation, NYHA class Ⅲ-IV, unstable angina pectoris, etc.
- 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).
- Patients with severe hyperlipidemia: (serum triglyceride ≥ 6.2 mmol/L, serum low-density lipoprotein cholesterol ≥ 4.1 mmol/L).
- Hyperkalemia that cannot be controlled through diet or potassium-lowering treatment.
- 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.
- Patients with a history of malignant tumors within the past five years.
- Patients with a known history of severe allergy to component blood or blood products, or patients with a history of allergy to heterologous proteins.
- 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.
- Active infection within one week before enrollment and requiring treatment with intravenous antibiotics.
- Patients who have participated in other interventional clinical trials within three months before enrollment.
- The research physician deems that the patient's condition is not suitable for participating in this clinical study.
Key Trial Info
Start Date :
June 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06969807
Start Date
June 9 2025
End Date
May 15 2028
Last Update
September 8 2025
Active Locations (6)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100010
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
3
Capital Medical University Affiliated Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
4
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053