Patent ID: 9034316
Filing Date: 2015-05-19
Classification: A61K,A61P,C12N

Abstract:
1. A method for treating adverse ventricular remodeling due to an infarct area injury resulting from acute myocardial infarction, comprising (a) acquiring from a subject that has suffered an acute myocardial infarction an isolated population of autologous mononuclear cells comprising CD34+ cells; (b) sterilely enriching the isolated population of autologous mononuclear cells for CD34+ cells, without expanding cell number in vitro, so that at least 70% of the cells comprise CD34+ cells; (c) at least 24 hours after step (a), passing a first portion of the enriched population produced in (b) through a catheter and confirming by testing in vitro that: (1) at least some of the cells passed through the catheter have CXCR-4-mediated chemotactic activity and move in response to SDF-1 in vitro; (2) at least 70% of the cells passed through the catheter are viable; and (3) at least some of the cells passed through the catheter can form hematopoietic colonies in vitro; (d) formulating for parenteral delivery through the catheter a sterile pharmaceutical composition comprising: (i) a therapeutic amount of a sterile isolated chemotactic hematopoietic stem cell product, wherein the therapeutic amount of the sterile isolated chemotactic hematopoietic stem cell product comprises a second portion of the enriched population produced in step (b) comprising at least 0.5×10 (ii) a stabilizing amount of serum, which is effective to retain the CXCR-4 mediated chemotactic activity and hematopoietic colony forming activity of the subpopulation of CD34+/CXCR-4+ cells that move in response to SDF-1 and (iii) a therapeutic amount of at least one compatible therapeutic agent selected from the group consisting of a diuretic, an anti-arrhythmic agent, an anti-anginal agent, a cytokine, a tyrosine kinase receptor agonist, a vasoactive agent, an anticoagulant agent, a fibrinolytic agent, a hypercholesterolemic agent, or a combination thereof, which is effective to promote function of the existing cardiomyocytes to compensate for loss of cardiomyocyte function due to cardiomyocyte death; and (e) administering to the subject parenterally through the catheter to treat the adverse ventricular remodeling at one or more infusion dates the sterile pharmaceutical composition.