Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease

Official title

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

Overview

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.

Interventions

• Drug Amimestrocel
  In the first month (day 1, 14, 28): 1×10\^6 cells per kilogram. From the 8th to the 24th week (week 8, 12, 16, 20, 24): 1.5×10\^6 cells per kilogram.

Primary outcome measures

• Urine protein [Time frame: Change from baseline at 24 weeks]
• estimated Glomerular Filtration Rate(eGFR) [Time frame: Change from baseline at 24 weeks]

Secondary outcome measures (12)

• fasting blood glucose [Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• HbA1c [Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• Urinary Albumin/Creatinine Ratio(UACR) [Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• proportion of outcome ( ≥50% declined in eGFR，reached end stage renal disease (ESRD), or occured Renal replacement) [Time frame: proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• proportion of major adverse cardiac events(MACE) and all-cause mortality [Time frame: proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• Mechanism exploration [Time frame: Change from baseline at 4,12,24 weeks and 12 months]
• changes in retinal imaging [Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• Changes in peripheral nerve injury [Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• Changes in symptoms [Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• Changes in the quality of life scale [Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• Adverse Event and Serious Adverse Event（SAE） [Time frame: within 28 weeks after received Amimestrocel]
• secondary malignant disease [Time frame: within 24 months after received Amimestrocel]

Eligibility criteria

Inclusion Criteria: -

• Men and women who are ≥18 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, or the urine albumin-to-creatinine ratio (UACR) > 1000 mg/g.
• The estimated glomerular filtration rate (eGFR) ≥ 15 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 6 centers

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

Identifiers

NCT: NCT06969807 · S2025-166 · S2025-166-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗