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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

• fasting blood glucose [Срок оценки: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• HbA1c [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Change from baseline at 4,12,24 weeks and 12 months]
• changes in retinal imaging [Срок оценки: 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 [Срок оценки: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion]
• Changes in symptoms [Срок оценки: 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 [Срок оценки: 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） [Срок оценки: within 28 weeks after received Amimestrocel]
• secondary malignant disease [Срок оценки: within 24 months after received Amimestrocel]

Критерии участия

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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