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Publication Number
US-8088370-B2
Publication Date
2012-01-03
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 cells having chemotactic activity, methods of preparing these compositions and use of these compositions to treat or repair vascular injury, including infarcted myocardium.
Core Innovation
The invention relates to a sterile pharmaceutical composition for repair of a vascular injury caused by vascular insufficiency. The composition comprises a vascular injury-repairing amount of a sterile chemotactic hematopoietic stem cell product together with a stabilizing amount of serum. The chemotactic hematopoietic stem cell product comprises a nonexpanded, isolated population of autologous mononuclear cells enriched for CD34+ cells and contains a subpopulation of potent CD34+ cells that express CXCR-4 and have CXCR-4-mediated chemotactic activity.
The composition is characterized by maintaining functional characteristics during the period following acquisition and during passage through a catheter. It is further 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.
In particular, the composition has at least 70% CD34+ cells, contains a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity, at least about 70% viable cells, and the ability to form hematopoietic colonies in vitro. The stabilizing amount of serum is greater than 20% (v/v), and the chemotactic cell product is provided as a nonexpanded isolated autologous CD34+ enriched population.
Claims Coverage
The document includes one independent claim. The inventive features center on a sterile chemotactic CD34+ cell product with a potent CXCR-4-expressing subpopulation, serum stabilization above 20% (v/v), and defined post-catheter in vitro retention properties for at least 24 hours.
Sterile composition for vascular injury repair with chemotactic CD34+ / CXCR-4 subpopulation
A sterile pharmaceutical composition for repair of a vascular injury caused by vascular insufficiency comprising a vascular injury-repairing amount of a sterile chemotactic hematopoietic stem cell product, wherein the product comprises a nonexpanded, isolated population of autologous mononuclear cells enriched for CD34+ cells, and contains a subpopulation of potent CD34+ cells that express CXCR-4 and have CXCR-4-mediated chemotactic activity.
Serum stabilization above 20% (v/v)
The composition further comprises a stabilizing amount of serum wherein the stabilizing amount of serum is greater than 20% (v/v).
Post-acquisition after catheter passage retention for at least 24 hours
The pharmaceutical composition is characterized as having, for at least 24 hours following acquisition of the chemotactic hematopoietic stem cell product when tested in vitro after passage through a catheter: at least 70% CD34+ cells, contains a subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity, at least about 70% viable cells, and is able to form hematopoietic colonies in vitro.
Overall, claim coverage centers on a sterile pharmaceutical composition combining a serum-stabilized, nonexpanded autologous CD34+ enriched chemotactic hematopoietic stem cell product with a potent CXCR-4-expressing subpopulation, together with defined functional retention criteria after in vitro testing following passage through a catheter for at least 24 hours.
Stated Advantages
Documented Applications
No documented applications found
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