Compositions and methods of vascular injury repair
Inventors
Pecora, Andrew L. • Preti, Robert A.
Assignees
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Publication Number
US-8343485-B2
Publication Date
2013-01-01
Expiration Date
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.
Core Innovation
The document describes a sterile pharmaceutical composition for repair of a vascular injury caused by vascular insufficiency in a subject in need thereof. The composition comprises a vascular injury-repairing amount of a sterile chemotactic hematopoietic stem cell product together with a stabilizing amount of serum at least 20% (v/v). The chemotactic hematopoietic stem cell product includes an isolated nonexpanded population of autologous mononuclear cells comprising a subpopulation of CD34+ cells and potent SDF-1-mobile CD34+/CXCR-4+ cells having CXCR-4-mediated chemotactic activity.
The composition is formulated for administration parenterally through a catheter and is characterized by properties for at least 24 hours following acquisition of the chemotactic hematopoietic stem cell product when tested in vitro after passage through a catheter. Following catheter passage, the composition maintains CD34+ content and viability and preserves the ability to form hematopoietic colonies in vitro for at least 24 hours.
The document further links the chemotactic hematopoietic stem cell product to catheter-based intravascular delivery. Catheter internal diameter is constrained to preserve cell potency during transit, and balloon catheterization into an infarcted coronary artery is described as used to treat vascular injury.
Claims Coverage
The provided claims coverage includes one independent claim and dependent refinements. The independent claim centers on 3 inventive features relating to the sterile chemotactic hematopoietic stem cell product, serum stabilization, and post-catheter maintenance of CD34+/CXCR-4/SDF-1-related potency, viability, and hematopoietic colony-forming ability.
Sterile chemotactic hematopoietic stem cell product for vascular injury repair
A vascular-injury-repairing amount of a sterile chemotactic hematopoietic stem cell product, wherein the product comprises an isolated nonexpanded population of autologous mononuclear cells comprising a subpopulation of CD34+ cells and potent SDF-1-mobile CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity.
Serum stabilization amount in a parenteral catheter formulation
A stabilizing amount of serum in a sterile pharmaceutical composition formulated for administration parenterally through a catheter.
Post-catheter maintenance of CD34+ subpopulations and potency
The pharmaceutical composition is characterized as having properties for at least 24 hours following acquisition of the chemotactic hematopoietic stem cell product when tested in vitro after passage through a catheter, including maintenance of CD34+ content and viability and the ability to form hematopoietic colonies in vitro.
The claims center on an isolated nonexpanded autologous mononuclear cell population enriched for potent SDF-1-mobile CD34+/CXCR-4+ cells with CXCR-4-mediated chemotactic activity, serum stabilization, and catheter-based parenteral formulation with defined in vitro retention of CD34+ content, viability, hematopoietic colony-forming ability, and chemotactic function for at least 24 hours after catheter passage.
Stated Advantages
Repairs a vascular injury caused by vascular insufficiency.
Maintains CD34+ content and viability and preserves the ability to form hematopoietic colonies in vitro for at least 24 hours following catheter passage when tested in vitro.
Preserves CXCR-4-mediated chemotactic activity associated with potent SDF-1-mobile CD34+/CXCR-4+ cells for at least 24 hours following catheter passage when tested in vitro.
Stabilizes the chemotactic hematopoietic stem cell product using serum at least 20% (v/v).
Documented Applications
Repair of a vascular injury caused by vascular insufficiency in a subject in need thereof.
Balloon catheterization into an infarcted coronary artery to treat vascular injury.
Myocardial ischemia caused by occlusion of the coronary artery.
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