AMI-DC in Patients With Anterior Wall Myocardial Infarction (AMI-DC)
Myocardial Infarction
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- Eun Ho ChooRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
AMI-DC
Standard treatment
Infusion of AMI-DC + Guideline directed optimal medical therapy
Control, Guideline directed optimal medical therapy