Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury

Обзор

This trial is to evaluate the efficacy and safety of Amimestrocel (human umbilical cord mesenchymal stromal cells) in the treatment of AKI patients.

Вмешательства

• Препарат Amimestrocel
  Amimestrocel will be administered at a target dose of 1×10\^6 MSCs/kg body weight on day 1, 4, 8, 15.

Первичные конечные точки

• serum creatinine [Срок оценки: Change from baseline at 28 days]

Вторичные конечные точки (9)

• serum creatinine [Срок оценки: Change from baseline at 8,15,21 days, and 2, 3 months.]
• Stage of AKI [Срок оценки: Change from baseline at 8, 15, 21, 28 days, and 2, 3 months.]
• proportion of study participants with Renal Replacement Therapy(RRT) [Срок оценки: proportion of study participants with RRT at 4, 8, 12 weeks and 12, 24 months]
• APACHE II or APACHE III [Срок оценки: Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months]
• SOFA [Срок оценки: Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months]
• all-cause mortality ratio [Срок оценки: All-cause mortality ratio at 28 days]
• Mechanism exploration [Срок оценки: Change from baseline at 8, 15, 28 days, 3 months.]
• Adverse Event and Serious Adverse Event [Срок оценки: Within 12 weeks after received Amimestrocel]
• secondary malignant disease [Срок оценки: Within 24 months after received Amimestrocel]

Критерии участия

Критерии включения

• Aged between 18 and 75 years old; gender is not restricted.
• According to the 2023 KDIGO diagnostic criteria for acute kidney injury (AKI), including those that occur during the course of the disease in various patients with chronic kidney disease (CKD), AKI can be diagnosed if any of the following conditions is met:

① The serum creatinine level increases by ≥ 26.5 μmol/L within 48 hours;

② The serum creatinine level increases by more than 1.5 times or higher than the baseline value within 7 days;

③ The urine output decreases (< 0.5 mL/kg/h) and persists for more than 6 hours; The baseline value of serum creatinine: The lowest creatinine value obtained in the outpatient department or ward within 3 months, and the longest time limit is the creatinine value within 1 year. If there is no such value, the serum creatinine can be estimated using the MDRD equation under the assumption that the baseline eGFR is 75 ml/min/1.73m².

• .Ability to give informed consent.

Критерии исключения

• Post-renal AKI.
• Acute kidney injury caused by glomerular diseases such as rapidly progressive glomerulonephritis, lupus nephritis, anti-neutrophil cytoplasmic antibody-associated nephritis, anti-glomerular basement membrane antibody-mediated nephritis, vasculitis, cryoglobulinemia, thrombotic microangiopathy, etc.
• Hemodynamic instability.
• Severe cardiovascular diseases.
• Severe pulmonary dysfunction.
• A history of intracerebral hemorrhage or cerebral infarction within the past six months.
• Subjects with abnormal laboratory indicators: AST or ALT > 5 × upper limit of normal value (ULN); total bilirubin > 3 × ULN; white blood cell count < 2000/μL (2 × 10⁹/L), hemoglobin < 6 g/dL (60 g/L), neutrophils < 1000/μL (1 × 10⁹/L), platelets < 50000/μL (50 × 10⁹/L).
• Uncontrollable infection.
• Patients with active hepatitis B or hepatitis C virus infection, active tuberculosis, severe immunodeficiency diseases, human immunodeficiency virus (HIV) infection, etc.
• Received systemic immunosuppressants or glucocorticoid treatment for more than one week within 30 days before enrollment.
• Have received hemodialysis or peritoneal dialysis treatment.
• Have a history of hematopoietic stem cell transplantation or solid organ transplantation.
• Patients with a history of malignant tumor within the past 5 years.
• Life expectancy is less than 1 month.
• Those with a known history of severe allergy to component blood or blood products, or those 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 fertility plan or a sperm donation plan from the start of the study to the follow-up period and are unwilling to take contraceptive measures.
• Patients who participated in other interventional clinical trials within 1 month before enrollment.

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: NCT06954740 · S2025-167 · S2025-167

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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