Compositions and methods for treating progressive myocardial injury due to a vascular insufficiency
OwnerAndrew L. Pecora, Robert A. Pretiinventors
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Abstract
The described invention provides methods and regimens for treating adverse consequences of a persistent and progressive myocardial injury-due to a vascular insufficiency that occurs early or late in a subject in need thereof, and progressive myocardial injury-preventing compositions that contain a chemotactic hematopoietic stem cell product, and, optionally, an additional active agent.
Claims38
A method of treating a progressive myocardial injury that is an adverse consequence of a vascular insufficiency, the method comprising the steps of:
- (a) acquiring a sterile nonexpanded, isolated population of autologous mononuclear cells comprising CD34+ cells, which further contain a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity from a subject under sterile conditions;
- (b) sterilely enriching the autologous mononuclear cells comprising CD34+ cells, wherein the enriched CD34+ cells which further contain a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity are a chemotactic hematopoietic stem cell product
- (c) administering parenterally through a catheter to a subject on a first infusion date a sterile pharmaceutical composition, wherein the sterile pharmaceutical composition comprises:
- (i) a therapeutically effective amount of the sterile chemotactic hematopoietic stem cell product,
- wherein the therapeutically effective amount of the chemotactic hematopoietic stem cell product comprises at least 10×106 CD34+ cells which further contain a subpopulation of at least 0.5×106 potent CD34+ cells expressing CXCR-4 and having CXCR-4 mediated chemotactic activity;
- and
- (ii) a stabilizing amount of serum, wherein the stabilizing amount of serum is greater than 20% (v/v),
- wherein the chemotactic hematopoietic stem cell product is further characterized as having the following properties for at least 24 hours when tested in vitro after passage through a catheter:
- (1) retains the CXCR-4-mediated activity of the chemotactic hematopoietic stem cell product;
- (2) at least 70% of the cells are CD34+ cells;
- (3) is at least 70% viable;
- and
- (4) is able to form hematopoietic colonies in vitro;
- (d) optionally administering the sterile pharmaceutical composition at a plurality of infusion dates during the subject's lifetime;
- wherein the therapeutically effective amount is effective to treat the progressive myocardial injury that is an adverse consequence of the vascular insufficiency.
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Dependencies are inferred from the claim text.