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US 2012/0071855 A1Published application
Compositions and methods of vascular injury repair
AssigneeAmorcyte, Inc.
InventorsAndrew L. Pecora, Robert A. Preti
Life of this patent
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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 CD34+/CXCR-4+ cells having CXCR-4-mediated chemotactic activity, methods of preparing these compositions and use of these compositions to treat or repair vascular injury, including infarcted myocardium.
Claims55
A sterile pharmaceutical composition for repair of a vascular injury caused by vascular insufficiency comprising:
- (a) a vascular injury-repairing amount of a sterile chemotactic hematopoietic stem cell product, wherein the vascular injury-repairing amount is effective to repair a vascular injury caused by vascular insufficiency, the chemotactic hematopoietic stem cell product comprising an isolated nonexpanded population of autologous mononuclear cells comprising a subpopulation of 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 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) the subpopulation of CD34+ cells comprises from at least about 1% to at least about 95% of the isolated nonexpanded population of autologous mononuclear cells,
- (ii) the subpopulation of CD34+ cells further contains a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity;
- (iii) the subpopulation of CD34+ cells comprises from at least about 1% to at least about 95% viable CD34+ cells;
- and
- (iv) the subpopulation of CD34+ cells is able to form hematopoietic colonies in vitro,
- wherein the stabilizing amount of serum is effective to enable the potent CD34+/CXCR-4+cells to retain their CXCR-4 mediated chemotactic activity and their hematopoietic colony forming ability.
6 more elements
A method of treating or repairing a vascular injury caused by vascular insufficiency in a subject in need thereof, comprising:
- parenterally administering to the subject through a catheter a sterile pharmaceutical composition comprising:
- (a) a vascular injury-repairing amount of a sterile chemotactic hematopoietic stem cell product, wherein the vascular injury-repairing amount is effective to repair a vascular injury caused by vascular insufficiency, the chemotactic hematopoietic stem cell product comprising an isolated nonexpanded population of autologous mononuclear cells comprising a subpopulation of 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 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) the subpopulation of CD34+ cells comprises from at least about 1% to at least about 95% of the isolated nonexpanded population of autologous mononuclear cells,
- (ii) the subpopulation of CD34+ cells further contains a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity;
- (iii) the subpopulation of CD34+ cells comprises from at least about 1% to at least about 95% viable CD34+ cells;
- and
- (iv) the subpopulation of CD34+ cells is able to form hematopoietic colonies in vitro,
- wherein the stabilizing amount of serum is effective to enable the potent CD34+/CXCR-4+cells to retain their CXCR-4 mediated chemotactic activity and their hematopoietic colony forming ability.
7 more elements
Dependencies are inferred from the claim text.