Compositions and methods of vascular injury repair
Inventors
Pecora, Andrew L. • Preti, Robert A.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-8637005-B2
Publication Date
2014-01-28
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
A method is described for treating or repairing a vascular injury caused by vascular insufficiency in a subject by parenterally administering through a catheter a sterile pharmaceutical composition. The composition includes a therapeutic amount of a sterile chemotactic hematopoietic stem cell product and a stabilizing amount of serum.
The chemotactic hematopoietic stem cell product comprises a nonexpanded isolated population of autologous mononuclear cells that includes CD34+ cells and a subpopulation of potent SDF-1-mobile CD34+/CXCR-4+ cells having CXCR-4-mediated chemotactic activity. The therapeutic amount includes at least 0.5×10^6 potent SDF-1 mobile CD34+/CXCR-4+ cells with CXCR-4-mediated chemotactic activity.
The stabilizing amount of serum is effective to retain CXCR-4-mediated chemotactic activity and hematopoietic colony forming activity of the subpopulation from completion of acquisition of the nonexpanded population to infusion, and the composition is characterized by properties for at least 24 hours following acquisition when tested in vitro after passage through the catheter. The CD34+ cells constitute from about 1% to about 95% of the isolated nonexpanded population, comprise from about 1% to about 95% viable CD34+ cells, and are able to form hematopoietic colonies in vitro.
Claims Coverage
The consolidated claim coverage centers on one independent claim with four inventive features, directed to catheter delivery of a sterile serum-stabilized autologous mononuclear chemotactic hematopoietic stem cell product for vascular injury repair.
Catheter-delivered sterile chemotactic hematopoietic stem cell composition for vascular injury repair
Parenterally administering through a catheter a sterile pharmaceutical composition effective to repair a vascular injury caused by vascular insufficiency, containing a therapeutic amount of a sterile chemotactic hematopoietic stem cell product and a stabilizing amount of serum.
Nonexpanded autologous mononuclear chemotactic CD34+ subpopulation with CXCR-4-mediated chemotaxis
The sterile chemotactic hematopoietic stem cell product comprises a nonexpanded isolated population of autologous mononuclear cells with CD34+ cells and a subpopulation of potent SDF-1-mobile CD34+/CXCR-4+ cells having CXCR-4-mediated chemotactic activity.
Therapeutic dose and serum stabilization to retain chemotactic and colony-forming activity
The therapeutic amount comprises at least 0.5×10^6 potent SDF-1 mobile CD34+/CXCR-4+ cells with CXCR-4-mediated chemotactic activity, and the serum is effective to retain CXCR-4-mediated chemotactic activity and hematopoietic colony forming activity from completion of acquisition to infusion.
Post-catheter retention and in-vitro characterization for at least 24 hours
The composition is characterized by properties for at least 24 hours following acquisition when tested in vitro after passage through the catheter, including CD34+ cell proportion, viable CD34+ cell proportion, presence of potent SDF-1 mobile CD34+/CXCR-4+ cells with CXCR-4-mediated chemotactic activity, and ability to form hematopoietic colonies in vitro.
The claim coverage combines catheter-based delivery, a nonexpanded autologous mononuclear stem cell product with CXCR-4-mediated SDF-1 chemotactic activity, serum stabilization, a defined therapeutic dose, and post-catheter in-vitro retention and colony-forming characterization.
Stated Advantages
Retains CXCR-4-mediated chemotactic activity and hematopoietic colony forming activity from completion of acquisition to infusion.
Preserves defined CD34+ subpopulation characteristics and ability to form hematopoietic colonies in vitro after catheter passage for at least 24 hours.
Documented Applications
Treating or repairing a vascular injury caused by vascular insufficiency in a subject.
Repair of vascular injury when vascular insufficiency is caused by occlusion of a coronary artery.
Interested in licensing this patent?