The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (The POSEIDON-Pilot Study)

Exclusion Criteria

• •Baseline glomerular filtration rate \<50 ml/min/1.73m2.
• •Presence of a mechanical aortic valve or heart constrictive device.
• •Documented presence of aortic stenosis (aortic stenosis graded as ≥+2 equivalent to an orifice area of 1.5cm2 or less).
• •Documented presence of moderate to severe aortic insufficiency (echocardio- graphic assessment of aortic insufficiency graded as ≥+2).
• •Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia ≥20 consecutive beats or complete heart block) or QTc interval \>550 ms on screening ECG. In addition; patients with sustained or a short run of ventricular tachycardia on ECG or 48 hour Ambulatory ECG during the screening period will be removed from the protocol.
• •Documented unstable angina.
• •AICD firing in the past 60 days prior to the procedure.
• •Be eligible for or require coronary artery revascularization.
• •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.
• •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 hepatitis C.
• •Female patient who is pregnant, nursing, or of child-bearing potential and not using effective birth control.