A Multi-center, Controlled, Open, Phase I Clinical Trial to Assess the Safety of AMI-DC (Autologous Dendritic Cells) Treatment in Patients With Acute Anterior Wall ST-segment Elevation Myocardial Infarction Who Received Reperfusion by Primary Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Primary Efficacy Outcome
研究概览
简要总结
The purpose of this trial is to assess the safety of AMI-DC treatment. The participants who voluntarily sign the consent form will be screened according to the inclusion/exclusion criteria then allocated either to the experimental group (drug therapy and AMI-DC therapy) or to the control group (drug therapy only). Both the experimental group and the control group are treated with standard medical therapy after PCI. The experimental group will be hospitalized for 4-5 days after 1st injection, and 1 day after 2nd injection. Vital signs are collected after 30 minutes, 1 hour, 2 hours and 4 hours after the 1st and 2nd injections and the subjects will be monitored 24 hours for safety assessment. The identical examination will also be performed in the control group and the results will be collected.
详细描述
The registration of study subjects follows two stages (stages A & B). In Stage A, 6 subjects in the experimental group and 3 subjects in the control group will sequentially be registered, then will be monitored for 10 weeks to assess safety. If Stage A passes the safety assessment, the rest will be recruited and randomly allocated to either experimental or control group in Stage B.
Approximately 300cc of whole blood will be collected only from patients assigned to the experimental group. The amount of blood collection can be supervised and adjusted at the discretion of the investigators. Collected blood will be cultured for 4 days to generate the dendritic cells. Then, 5~10x106 cells are administered subcutaneously at 1-4 sites in the left axillary regions between 5-7 days after PCI and between 12-14 days after PCI.
Echocardiography and cardiac MRI will be examined for any signs of adverse reaction to ensure safety and evaluate cardiac functions at baseline and after 6 months.
- In stage A, 6 people are sequentially allocated to the experimental group and 3 people are sequentially allocated to the control group.
- The experimental group are monitored for 10 weeks following the 2nd AMI-DC to assess safety. Stage B is implemented once determined safe to proceed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers who qualify all the following conditions
- •Between the ages 19 through 80
- •Patients within 24 hours from primary PCI with a diagnosis of acute anterior wall ST-segment elevation myocardial infarction and systolic dysfunction:
- •acute myocardial infarction patient with an electrocardiogram (12-lead ECG) result corresponding to any of the following (ST-segment elevation 0.1 mV in two or more limb leads or 0.2 mV elevation in two or more contiguous precordial leads)
- •Left ventricular ejection fraction (LVEF) below 50% by echocardiography
- •Hemodynamically stable (SBP >100 mmHg, HR <110 bpm, SO2 >95%)
- •Able-bodied for collection of approximately 300cc of blood for generation of autologous dendritic cells who qualify the following conditions
- •Body weight: 50 kg or above for men, 45 kg or above for women
- •Hb level of 12.0 g/dL or above 5) Signed the written consent form for this clinical trial
排除标准
- •Volunteers who correspond to any of the following conditions
- •LV thrombus
- •Difficulty in accessing femoral artery for sheath insertion due to peripheral artery disease
- •Previous history of PCI, CABG due to myocardial infarction
- •Renal failure: serum Creatinine >2.5 mg/dL
- •Acute or chronic infections
- •Known contraindications to MRI
- •Hemorrhagic disorders (PT INR >2)
- •History of malignant tumor within 5 years
- •A life expectancy of 1 year or less
- •Tested positive with HIV, HBV, HCV and/or syphilis
- •Autoimmune disease
- •Pregnant or nursing mothers
- •Participated in other clinical trials within past 30 days
- •Deemed unfit for this clinical trial by the investigators
- •Disagreed to use an approved method of contraception (Men: vasectomy, double diaphragm, or effective contraception used by the partner. Women: IUD, IUS or hormonal contraceptives) during the trial period.
- •Moderate-to-severe liver disease (ALT is more than 5 times the upper limit of normal)
- •Acute myocardial infarction patients at high bleeding risk with Hb 11g/dL or more Use or are scheduled to use oral anticoagulants for a long period of time Spontaneous hemorrhage that required hospitalization or blood transfusion within the past 6 months Thrombocytopenia (platelet count of <100x109/L) Liver cirrhosis with portal hypertension Severe ischemic stroke within the past 6 months, with spontaneous intracerebral hemorrhage and cerebrovascular malformation Major surgery or severe injury within the past 30 days
结局指标
主要结局
Primary Efficacy Outcome
时间窗: up to 6 months
Cumulated incidence ratio of MACE (death from any cause, HF admission, VT/VF, stroke) at 6 months
Primary Safety Outcome 1
时间窗: Up to 6 months
Occurrence of Ventricular Arrhythmias, Perforation, Myocardial Ischemia, or Any sign of infection that occur during the entire study period
Primary Safety Outcome 2
时间窗: Week 12
Occurrence of Ventricular Arrhythmia or Bradyarrhythmia in 24-hour Holter monitoring at 12 weeks.
次要结局
- Change in LV wall motion(up to 6 months)
- Change in C-reactive protein (CRP)(up to 6 months)
- Change in patients' HF symptom(up to 6 months)
- Change in left ventricular ejection fraction(up to 6 months)
- Change in LV chamber(up to 6 months)
- Change in white blood cell count(up to 6 months)
- Change in polarization of lymphocyte by FACS(up to 12 weeks)
- Change in serum cytokine(up to 12 weeks)
- Change in infarct size(up to 6 months)
- Change in NT-proBNP(up to 6 months)
研究者
Kiyuk Chang, MD,PhD
Professor
The Catholic University of Korea