The Enhanced Angiogenic Cell Therapy - Acute Myocardial Infarction Trial

Korábbi kezelés

• A history of left ventricular dysfunction prior to index STEMI
• Is enrolled in a current investigational drug or device trial
• Participant has received cell or gene therapy in past

Más betegség

• Significant unprotected left main disease (stenosis of 50% or greater on diagnostic angiography)
• A history of significant ventricular arrhythmia NOT related to index STEMI
• A history of cerebro-vascular accident or transient ischemic attack within 6 months of enrollment
• A history of uncorrected significant valvular heart disease
• A history of human immunodeficiency virus (HIV) or hepatitis B or C infection
• A history of malignancy within 5 years (Except for low-grade and fully resolved non-melanoma skin cancer)
• A history of allergy to gentamycin or amphotericin
• A history of Heparin-Induced Thrombocytopenia (HIT)
• A history of non-compliance
• Active inflammatory autoimmune disease requiring chronic immunosuppressive therapy

Laborértékek

• An increase in LVEF by greater that 10% from initial LVEF evaluation for repeat assessments
• Inability to undergo apheresis procedure (i.e.: poor venous access, laboratory abnormalities)
• Creatinine clearance <60 by Cockcroft-Gault Calculator

Egyéb

• The presence of significant coronary lesions, other than the index lesion of the IRA
• Meets at least one exclusion criterion for MRI (NB: Recent stent implantation is not an exclusion)
• Confirmed pregnant or lactating
• The presence of any significant co-morbidities that, in the investigator's opinion, would preclude the participant from taking part in the trial
• Inability to provide informed consent and comply with the follow-up visit schedule

• Male or female 18-80 years of age
• Clinical diagnosis of anterior ST-elevation myocardial infarction within the last 30 days, with any one of the following 12-lead electrocardiographic changes:
• a) Greater than or equal to 1 mm ST elevation or new Q waves in 2 adjacent electrocardiographic precordial leads
• b) A new left bundle branch block AND and for patients presenting within 3 days of onset of chest pain an increase in cardiospecific enzymes (>3x CK with, EITHER positive MB fraction or increase in troponin compared to institution laboratory normal ranges)
• Successful PCI with stent implantation to infarct-related artery within the last 30 days; defined as residual stenosis no greater than 30%, TIMI flow of at least 2 or greater and a reference diameter of at least > 2mm
• Is considered hemodynamically stable at time of enrollment and immediately prior to cell delivery
• Screening LVEF must be no greater than 45% by echocardiography (determined by Simpson's method) performed at least 4 days after revascularization procedure. (All screening echos done within the first 4 days post-PCI must be repeated either by echocardiography or MRI prior to cell delivery to ensure that the variability does not exceed 10%)
• In the case of a previous myocardial infarction, documented LVEF must be 55% or greater
• Female participants MUST be surgically sterile, post-menopausal, have documented infertility, or are of child-bearing potential wih laboratory confirmation of non-pregnant state
• Provided written informed consent and is willing to comply with study follow-up visits