Patent ID: 9533010
Date: 2017-01-03
CPC Classifications: A61K,C12N

Claim:
1. A method of reducing progressive expansion of an area of infarcted myocardium after an acute myocardial infarction in a subject whose condition is at risk for disease progression to heart failure, comprising: (a) first, acquiring from the subject, under sterile conditions, a population of mononuclear cells comprising CD34+ cells; (b) second, sterilely enriching the population of mononuclear cells comprising CD34+ cells for CD34+ cells to produce enriched CD34+ cells; (c) third, confirming that a subpopulation of potent CD34+/CXCR-4+ cells, when tested in vitro after passage through a catheter for at least 24 hours after acquiring step (a): (i) have CXCR-4 mediated chemotactic activity and move in response to SDF-1; (ii) can form hematopoietic colonies; and (iii) are at least 70% viable; (d) fourth, formulating for delivery parenterally through a catheter a sterile pharmaceutical composition, comprising: (i) a second portion of the enriched population produced in step (b), which contains a therapeutic amount of at least 10 million CD34+ cells comprising at least 0.5×10 (ii) a stabilizing amount of serum of at least 10% (v/v), wherein the stabilizing amount of serum is effective to retain the CXCR-4 mediated chemotactic activity and hematopoietic colony forming activity of the subpopulation of CD34+/CXCR-4+ cells in (d)(i); (e) fifth, treating the subject by administering the sterile pharmaceutical composition to the subject parenterally on a first infusion date; (f) sixth, repeating steps (b)-(d), in order, and optionally step (a), at a plurality of infusion dates; wherein a therapeutic amount of the composition is effective to produce a therapeutic effect comprising a paracrine effect, a neoangiogenic effect, or a combination thereof in a peri-infarct border zone that extends beyond the area of infarcted myocardium; and wherein the therapeutic effect is effective to reduce progressive myocardial cell loss due to cardiomyocyte cell death in the peri-infarct border zone; to treat hypoperfusion in the peri-infarct border zone, to treat myocardial hibernation in the peri-infarct border zone, or a combination thereof, relative to controls, and to reduce disease progression to heart failure during the subject's lifetime.