Compositions and methods of vascular injury repair
First Claim
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1. A sterile pharmaceutical composition for repairing a vascular injury in a subject in need thereof,wherein the vascular injury is an acute myocardial infarction resulting from underlying diseases and the subject is a revascularized subject,the sterile pharmaceutical composition comprising:
- (a) a therapeutically effective amount of a sterile chemotactic hematopoietic stem cell product, the chemotactic hematopoietic stem cell product comprising a nonexpanded, isolated population of autologous mononuclear cells enriched for CD34+ cells, which further contains a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity; and
(b) a stabilizing amount of serum, wherein the stabilizing amount of serum is greater than 20% (v/v),wherein the pharmaceutical composition is further characterized as having the following properties for at least 24 hours following acquisition of the chemotactic hematopoietic stem cell product when tested in vitro after passage through a catheter;
(i) at least 70% of the cells are CD34+ cells;
(ii) contains a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity;
(iii) is at least 70% viable; and
(iv) is able to form hematopoietic colonies in vitro.
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Abstract
The present invention relates to pharmaceutical compositions comprising a chemotactic hematopoietic stem cell product comprising an enriched population of CD34+ cells containing a subpopulation of cells having chemotactic activity, methods of preparing these compositions and use of these compositions to treat or repair vascular injury, including infarcted myocardium.
55 Citations
38 Claims
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1. A sterile pharmaceutical composition for repairing a vascular injury in a subject in need thereof,
wherein the vascular injury is an acute myocardial infarction resulting from underlying diseases and the subject is a revascularized subject, the sterile pharmaceutical composition comprising: -
(a) a therapeutically effective amount of a sterile chemotactic hematopoietic stem cell product, the chemotactic hematopoietic stem cell product comprising a nonexpanded, isolated population of autologous mononuclear cells enriched for CD34+ cells, which further contains a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity; and (b) a stabilizing amount of serum, wherein the stabilizing amount of serum is greater than 20% (v/v), wherein the pharmaceutical composition is further characterized as having the following properties for at least 24 hours following acquisition of the chemotactic hematopoietic stem cell product when tested in vitro after passage through a catheter; (i) at least 70% of the cells are CD34+ cells; (ii) contains a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity; (iii) is at least 70% viable; and (iv) is able to form hematopoietic colonies in vitro. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A method of treating or repairing a vascular injury in a subject in need thereof, wherein the vascular injury is an acute myocardial infarction resulting from underlying diseases and the subject is a revascularized subject, comprising:
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parenterally administering to the subject through a catheter a sterile pharmaceutical composition comprising; (a) a therapeutically effective amount of a chemotactic hematopoietic stem cell product, the chemotactic hematopoietic stem cell product comprising a nonexpanded, isolated population of autologous mononuclear cells enriched for CD34+ cells, which further contains a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity; and (b) a stabilizing amount of serum, wherein the stabilizing amount of serum is greater than 20% (v/v), wherein the sterile pharmaceutical composition is further characterized as having the following properties for at least 24 hours following acquisition of the chemotactic hematopoietic stem cell product when tested in vitro after passage through a catheter; (i) at least 70% of the cells are CD34+ cells; (ii) contains a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity; (iii) is at least 70% viable; and (iv) is able to form hematopoietic colonies in vitro, wherein the administration is performed during a specific time interval defined as being after peak inflammatory cytokine cascade production in the infarcted area and before completion of myocardial scar formation in the infarcted area. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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Specification