Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)
Condition: Left Ventricular Dysfunction
MeSH terms: Myocardial Infarction; Ventricular Dysfunction; Ventricular Dysfunction, Left
Intervention: Adult stem cells; Placebo
Intervention description: One time infusion of approximately 150 million total nucleated cells (TNC) in 30 ml of 5% HSA/saline solution; One time infusion of 30 ml of HSA (5%)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Acute Myocardial Infarction; Global Left Ventricular Ejection Fraction; Regional Left Ventricular Ejection Fraction; Left Ventricular Mass; Infarct Size; End Systolic Volume; End Diastolic Volume

Summary:

      Heart attacks are a leading cause of death for both men and women in the United States. A
      heart attack occurs when blood flow to the heart is restricted, commonly due to a blood clot
      that has formed in one of the coronary arteries. If the clot becomes large enough, blood flow
      to the heart can be blocked almost completely and the heart muscle in that area can suffer
      permanent injury or death. Although a percutaneous coronary intervention (PCI) can be used to
      open up the blocked artery and restore blood flow to the heart muscle, there may be a
      significant amount of heart tissue that has been irreversibly damaged. Recent studies have
      shown that adult stem cells from bone marrow may be able to improve heart function after a
      heart attack. This study will evaluate the safety and effectiveness of using adult stem cells
      for improving heart function in people who have had a recent heart attack and a PCI.
    

Eligibility criteria:

        Inclusion criteria

          1. Patients at least 21 years of age

          2. Patients with first acute MI with successful primary percutaneous coronary
             intervention (PCI) in an artery at least 2.5 mm in diameter within 24 hours of onset
             of symptoms.

          3. No contraindications to undergoing cell therapy procedure within three to seven days
             following AMI and PCI.

          4. Hemodynamic stability as defined as no requirement for IABP, inotropic or blood
             pressure supporting medications.

          5. Ejection fraction following reperfusion with PCI <=45% as assessed by
             echocardiography.

          6. Consent to protocol and agree to comply with all follow-up visits and studies.

          7. Women of child bearing potential willing to use an active form of birth control.

        Exclusion criteria

        Patients will be excluded from the study if they meet any of the following conditions:

          1. History of sustained ventricular arrhythmias not related to their AMI (evidenced by
             previous holter monitoring and/or medication history for sustained ventricular
             arrhythmias in patient's medical chart).

          2. Require CABG or PCI due to the presence of residual coronary stenosis >70% luminal
             obstruction in the non-infarct related vessel (Additional 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. History of thrombocytopenia in the absence of recent evidence that platelet counts are
             normal

          7. Known history of elevated INR (PT) or PTT.

          8. Life expectancy less than one year.

          9. History of untreated alcohol or drug abuse.

         10. Currently enrolled in another investigational drug or device trial

         11. Previous CABG.

         12. Previous MI resulting in LV dysfunction (LVEF <55%)

         13. History of stroke or transient ischemic attack (TIA) within the past six months.

         14. History of severe valvular heart disease (aortic valve area <1.0 cm2 or >3+ mitral
             regurgitation).

         15. Pregnancy or breast feeding

         16. Subjects with a known history of HIV, or has active hepatitis B,active hepatitis C, or
             active TB

         17. Patients with active inflammatory or autoimmune disease on chronic immuno-suppressive
             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 child bearing potential not willing to practice an active form of birth control.

         21. Chronic liver disease that might interfere with survival or treatment with cell
             therapy.

         22. Chronic renal insufficiency as defined by a creatinine ≥ 2.0 mg/dL or requires chronic
             dialysis.