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INFARCT AREA PERFUSION-IMPROVING COMPOSITIONS AND METHODS OF VASCULAR INJURY REPAIR

  • US 20100143317A1
  • Filed: 12/02/2009
  • Published: 06/10/2010
  • Est. Priority Date: 10/24/2006
  • Status: Active Grant
First Claim
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1. A method of treating or repairing an infarct area injury in a revascularized subject following an acute myocardial infarction resulting from a natural disease process, the method comprising the steps:

  • (a) administering to the subject parenterally through a catheter a sterile pharmaceutical composition comprising;

    (i) an infarct area perfusion-improving amount of a nonexpanded sterile isolated chemotactic hematopoietic stem cell product as a first therapeutic agent,wherein the infarct area perfusion-improving amount of the chemotactic hematopoietic stem cell product comprises an enriched population of isolated autologous CD34+ hematopoietic stem cells containing a subpopulation of potent CD34+ cells expressing CXCR-4 and having CXCR-4 mediated chemotactic activity such that the enriched population of isolated autologous CD34+ hematopoietic stem cells provides at least 0.5×

    106 potent CD34+ cells expressing CXCR-4 and having CXCR-4 mediated chemotactic activity;

    (ii) a stabilizing amount of serum, wherein the stabilizing amount of serum is greater than 20% (v/v), and(iii) optionally a therapeutically effective amount of at least one compatible second therapeutic agent; and

    (b) improving perfusion in at least one infarct area, relative to controls,wherein at least 70% of cells in the enriched population of isolated CD34+ cells containing the subpopulation of potent cells that express CXCR-4 and that have CXCR-4-mediated chemotactic activity when passed through the catheter and when tested in vitro are CD34+ cells, andwherein the enriched population of isolated CD34+ cells containing a subpopulation of potent cells that express CXCR-4 and that have CXCR-4-mediated chemotactic activity when passed through the catheter and tested in vitro;

    (1) retains the CXCR-4-mediated chemotactic activity;

    (2) is at least about 70% viable; and

    (3) is able to form hematopoietic colonies in vitrofor at least about 24 hours following acquisition from the subject of the enriched population of CD34+ cells containing the subpopulation of potent cells that express CXCR-4; and

    wherein administering step (a) occurs at one or more infusion dates, andwherein a first infusion date comprises a specific time interval defined by a first time and a second time, wherein the first time is after peak inflammatory cytokine cascade production in the infarcted area and the second time is before myocardial scar formation in the infarcted area.

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