NCT06954740招募中2 期
Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury
Chinese PLA General Hospital9 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- serum creatinine
研究概览
简要总结
This trial is to evaluate the efficacy and safety of Amimestrocel (human umbilical cord mesenchymal stromal cells) in the treatment of AKI patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Amimestrocel
Experimental
In experimental group,patients receive standard treatment and Amimestrocel is administered via Intravenous infusion on day 1, 4, 8,15.
干预措施: Amimestrocel (Drug)
结局指标
主要结局
serum creatinine
时间窗: Change from baseline at 28 days
次要结局
- serum creatinine(Change from baseline at 8,15,21 days, and 2, 3 months.)
- Stage of AKI(Change from baseline at 8, 15, 21, 28 days, and 2, 3 months.)
- proportion of study participants with Renal Replacement Therapy(RRT)(proportion of study participants with RRT at 4, 8, 12 weeks and 12, 24 months)
- APACHE II or APACHE III(Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months)
- SOFA(Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months)
- all-cause mortality ratio(All-cause mortality ratio at 28 days)
- Mechanism exploration(Change from baseline at 8, 15, 28 days, 3 months.)
- Adverse Event and Serious Adverse Event(Within 12 weeks after received Amimestrocel)
- secondary malignant disease(Within 24 months after received Amimestrocel)
- serum creatinine(Change from baseline at 8,15,21 days, and 2, 3 months.)
- Stage of AKI(Change from baseline at 8, 15, 21, 28 days, and 2, 3 months.)
- proportion of study participants with Renal Replacement Therapy(RRT)(proportion of study participants with RRT at 4, 8, 12 weeks and 12, 24 months)
- APACHE II or APACHE III(Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months)
- SOFA(Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months)
- all-cause mortality ratio(All-cause mortality ratio at 28 days)
- Mechanism exploration(Change from baseline at 8, 15, 28 days, 3 months.)
- Adverse Event and Serious Adverse Event(Within 12 weeks after received Amimestrocel)
- secondary malignant disease(Within 24 months after received Amimestrocel)
研究者
Chen Xiangmei
Principal Investigator
Chinese PLA General Hospital
研究点 (9)
Loading locations...
相似试验
Unknown
1 期
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Exosomes in Treating Chronic Cough After COVID-19Long COVID-19 SyndromeNCT05808400Huazhong University of Science and Technology80
招募中
1 期
Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic SclerosisSclerosis, SystemicMesenchymal Stem CellsNCT04356287Marie Hudson, MD18
尚未招募
2 期
Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-SA) for Patients With Spinocerebellar AtaxiaSpinocerebellar Ataxia Type 3Spinocerebellar Ataxia Type 2Spinocerebellar Ataxia Type 1Spinocerebellar Ataxia Type 6NCT03378414Sclnow Biotechnology Co., Ltd.45
尚未招募
1 期
Clinical Study on the Safety and Preliminary Efficacy of hUC-MSCs Intravenous Infusion Therapy for ARDSAcute Respiratory Distress SyndromeNCT06505941Southeast University, China60
招募中
3 期
UC-MSCs in the Treatment of Severe and Critical COVID-19 PatientsMesenchymal Stem CellCOVID-19 PneumoniaNCT05682586Shanghai East Hospital60