Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease
Recruiting now · Phase 2
Conditions studied: Diabetic Kidney Disease (DKD)
In brief
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 whether Amimestrocel can improve renal function or proteinuria of DKD patients.
Key facts
- Study ID
- NCT06969807
- Run by
- Chinese PLA General Hospital
- People needed
- 120
- Starts
- 2025-06-09
- Expected to finish
- 2028-05-15
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Beijing Hospital — Beijing, Beijing Municipality, China (enrolling)
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
- Capital Medical University Affiliated Beijing Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)
- Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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