Subacute Recovery Phase of ST-Elevation Myocardial Infarction (recent MI)
ST-elevation is a measurement on an electrocardiogram in which the trace in the ST segment is very high above the isoelectric line. If the cardiac muscle becomes damaged or inflamed its electrical properties transform, and often patients will show an ST-elevation. Angeles hospital offers stem cell application for this. The inclusion and exclusion criteria is as follows:
• Males and Females between Age 18 and 80 years.
• Defined acute myocardial infarction between 2 weeks and 4 months from screening
• Left ventricular ejection fraction at screening of ≤ 45%, with 2 or more contiguous areas of severe wall motion abnormality on resting echocardiography.
• Patients must have a minimum myocardial wall thickness of 5mm
• Need or feasibility for re-vascularization has been ruled out by coronary angiogram or noninvasive stress testing.
• Stable for at least 30 days on optimal medical management including:
o Plavix/asprin therapy, anticoagulation therapy, cholesterol lowering agent, beta blocker, ACE inhibitor or ARB blocker
At the time of the screening/enrollment visit #1, patients meeting ANY ONE of the following criteria will be excluded from the study.
• Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
• Inability to undergo Lipivage™ fat transfer procedure or have any medical problems that contraindicate the LipiVage procedure.
• Life expectancy < 6 months due to concomitant illnesses. • NYHA CHF Class 3+ or 4 • Severe valvular or other non-ischemic myocardial disease. • Mechanical complications of the index acute myocardial infarction including but not limited to rupture of the mitral valve with resultant development of mitral regurgitation, rupture of the left ventricular free wall and rupture of the interventricular septum. • Previous severe reaction to radiocontrast agents • Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. • Serum creatinine > 2.5 mg/dL or end stage renal disease
• Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. If the panel includes antibodies to the HBVcAg and HBV-sAg, then an expert will be consulted as to patient eligibility based on the patient’s infectious status
• Any illness which might affect a patient’s survival over the follow-up period
• Any illness which, in the Investigator’s judgement, will interfere with the patient’s ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
• Patients on chronic immunosuppressive transplant therapy
• Patients with severe coagulation disorders
• Systolic blood pressure (supine) ≤90 mmHg;
• Resting heart rate > 100 bpm;
• Poorly controlled diabetes mellitus (HgbA1C>10%).
• Active proliferative diabetic retinopathy
• Medical risk that precludes anesthesia (conscious sedation), or ASA Class 5.
• Active clinical infection being treated by antibiotics within one week of enrollment.
• Cerebrovascular accident within 6 months prior to study entry
• Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
• COPD or severe asthma that would contraindicate surgery (LipiVage).
• History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last two years.
• Unwilling and/or not able to give written informed consent.