PercutaneOus StEm Cell Injection Delivery Effects On Neomyogenesis in Dilated CardioMyopathy (The POSEIDON-DCM Study)

Exclusion Criteria

• •Baseline glomerular filtration rate equal or \< 45 ml/min/1.73m2.
• •Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of nonischemic dilated cardiomyopathy.
• •Presence of a prosthetic aortic valve or heart constrictive device.
• •Presence of a prosthetic mitral valve.
• •Previous myocardial infarction (MI) as documented by a clinical history that will include an elevation of cardiac enzymes and/or ECG changes consistent with MI.
• •Diagnosis of nonischemic dilated cardiomyopathy due to valvular dysfunction, mitral regurgitation, tachycardia, or myocarditis.
• •Previous treatment for post-infarction left ventricular dysfunction including PCI and thrombolytic therapy.
• •Documented presence of a known LV thrombus, aortic dissection, or aortic aneurysm.
• •Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries.
• •Documented presence of aortic stenosis (aortic stenosis graded as 1.5cm2 or less).
• •Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
• •Evidence of a life-threatening arrhythmia in the absence of a defibrillator (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete second or third degree heart block in the absence of a functioning pacemaker) or QTc interval \> 550 ms on screening ECG.
• •AICD firing in the past 30 days prior to the procedure
• •Be eligible for or require coronary artery revascularization.
• •Diabetic with poorly controlled blood glucose levels and/or evidence of proliferative retinopathy.
• •Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet values \< 100,000/ul without another explanation.
• •Have liver dysfunction, as evidenced by enzymes (ALT and AST) greater than three times the ULN.
• •Have a coagulopathy condition = (INR \> 1.3) not due to a reversible cause.
• •Known, serious radiographic contrast allergy.
• •Known allergies to penicillin or streptomycin.
• •Organ transplant recipient.
• •Have a history of organ or cell transplant rejection
• •Clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
• •Non-cardiac condition that limits lifespan to \< 1 year.
• •On chronic therapy with immunosuppressant medication.
• •Serum positive for HIV, hepatitis BsAg, or viremic hepatitis C.
• •Female patient who is pregnant, nursing, or of child-bearing potential and not using effective birth control.
• •Have a history of drug or alcohol abuse within the past 24 months.
• •Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.