ad-hgf treatment for myocardial infarction

Conditions: Myocardial Infarction

Summary: this will be the first clinical trial use ad-hgf gene for the treatment of myocardial infarction disease.


Eligibility criteria:
inclusion criteria: * male or female 18-80 years of age * clinical diagnosis of anterior st-segment elevation myocardial infarction (stemi) within the last 30 days, with any one of the following 12-lead electrocardiographic changes: * a) greater than or equal to 2 mm st-segment elevation) in 2 adjacent electrocardiographic precordial leads * b) a new left bundle branch block and and an increase in cardiospecific enzymes \>3x ck, 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%, thrombolysis in myocardial infarction (timi) flow of at least 2 and a reference diameter of at least \> 2mm * is considered hemodynamically stable at time of enrollment and immediately prior to ad-hgf delivery * screening lvef for the first 12 enrolled participants, must be no greater than 40% by echocardiography (determined by simpson's method) performed at least 2 days after revascularization procedure. subsequent participants enrolled in the trial, must have an lvef no greater than 45%. (all screening echos done within the first 4 days post percutaneous coronary intervention (pci) must be repeated either by echocardiography or mri prior to ad-hgf delivery to ensure that the variability does not exceed 10%) * in the case of a previous myocardial infarction, documented lvef must be 50% 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 exclusion criteria: * significant unprotected left main disease (stenosis of 50% or greater)on diagnostic angiography * an increase in lvef by greater that 10% from initial lvef evaluation for repeat assessments * the presence of significant coronary lesions, other than the index lesion of the infarction related artery * 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 * inability to undergo apheresis procedure(i.e.: poor venous access, laboratory abnormalities * a history of uncorrected significant valvular heart disease * a history of left ventricular dysfunction prior to index stemi * 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 non-compliance * active inflammatory autoimmune disease requiring chronic immunosuppressive therapy * creatinine clearance \<60 by cockcroft-gault calculator * confirmed pregnant or lactating * is enrolled in a current investigational drug or device trial * participant has received cell or gene therapy in past * 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

Keywords: hgf,myocardial infarction