Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)
Condition: Left Ventricular Dysfunction
MeSH terms: 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: 87.0
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:

      More than 1 million Americans suffer heart attacks each year. Although current treatments are
      able to stabilize the condition of the heart, none is able to restore heart function as it
      was prior to the heart attack. Adult stem cells, which are immature cells that can become
      many different types of cells, may offer a potential means of reversing or preventing
      permanent damage caused by a heart attack. Recent studies have shown promise in using adult
      stem cells from bone marrow to reverse damage to the heart muscle caused by a heart attack,
      but more research is needed to assess the safety and effectiveness of stem cell use and to
      discover the best time to administer treatment. This study will evaluate the safety and
      effectiveness of using adult stem cell infusions 2 to 3 weeks after a heart attack for
      improving heart function in people who have had a recent heart attack and a common procedure
      called a percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion criteria

          1. Patients at least 21 years of age.

          2. Patients with first acute MI and subsequent successful primary percutaneous coronary
             intervention (PCI) in an artery at least 2.5 mm in diameter occurring two to three
             weeks before recruitment.

          3. No contraindications to undergoing cell therapy procedure within two to three weeks
             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 tuberculosis (TB)

         17. 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 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.