Table 1.
Inclusion and Exclusion Criteria for TIME
| Inclusion Criteria |
| 1) Patients at least 21 years of age |
| 2) Patients with first acute anterior MI with successful primary percutaneous coronary intervention (PCI) in the LAD artery at least 2.5 mm in diameter within 24 hours of onset of symptoms. |
| 3) Hemodynamic stability as defined as no requirement for IABP, inotropic or blood pressure supporting medications. |
| 4) Ejection fraction following reperfusion with PCI ≤45% as assessed by echocardiography. |
| 5) Consent to protocol and agree to comply with all follow-up visits and studies. |
| 6) Women of child bearing potential willing to use an active form of birth control. |
| Exclusion Criteria |
| 1) History of sustained ventricular arrythmias not related to their AMI (evidenced by previous Holter monitoring and/or medication history for sustained ventricular arrhythmias in patient’s medication chart). |
| 2) Requires CABG or PCI due to the presence of residual coronary stenosis >70% luminal obstruction in the non-infarct related vessel (Additionally PCI of non-culprit vessels may be performed prior to enrollment). |
| 3) History of any malignancy within the past five years excluding non-melanoma skin cancer or cervical cancer in-situ. |
| 4) History of chronic anemia (hemoglobin (Hb) <9.0 mg/dl). |
| 5) History of thrombocytosis (platelets >500k). |
| 6) Baseline platelet count (prior to revascularization) < 120,000 or known history of thrombocytopenia. |
| 7) Known history of elevated INR (PT) or PTT. |
| 8) Life expectancy less than one year. |
| 8) History of untreated alcohol or drug abuse. |
| 9) Currently enrolled in another investigational drug or device trial |
| 10) Previous CABG. |
| 11) Previous MI or history of non-ischemic cardiomyopathy resulting in LV dysfunction (LVEF <55%) |
| 12) History of stroke or transient ischemic attack (TIA) within the past six months. |
| 13) History of severe valvular heart disease (aortic valve area < 1.0 cm2 or > 3+ mitral regurgitation). |
| 14) Pregnancy or breast feeding |
| 15) Subjects with a known history of HIV, hepatitis B or C infection, or TB positive therapy. |
| 16) Patients with active inflammatory or autoimmune disease on chronic immunosuppressive therapy. |
| 18) Contraindications to cMRI. |
| 19) Previous radiation to the pelvis with white blood cell count (WBC) and platelet counts below hospital specific normal values. |
| 20) Women of child-bearing potential not willing to practice an active form of birth control. |
| 21) Hepatic dysfunction as defined by: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN); or, Total bilirubin ≥2 times ULN with AST or ALT ≥2 times ULN. |
| 22) Chronic renal insufficiency as defined by a creatinine ≥ 2.0 mg/dl or requires chronic dialysis. |
| 23) The revascularized vessel is not patent at the time cell administration is to be attempted. |
| 24) Patient with two or more of the following criteria will be excluded from the trial, unless the LVEF is less than 30%: |
| 1. Onset of symptoms to treatment PCI< 2 hours |
| 2. Peak CK < 1500 IU/ml |
| 3. Absence of q-wave on Day 1 EKG (post stenting). |
| 4. Age < 45 years |