Patent ID: 8709403

Claim:
A sterile pharmaceutical composition formulated for administration parenterally through a catheter comprising: (a) a therapeutic amount of a sterile chemotactic hematopoietic stem cell product, the chemotactic hematopoietic stem cell product comprising a nonexpanded population of mononuclear cells enriched for CD34+ cells, which further contain a subpopulation of potent CD34+/CXCR-4+ cells that move in response to SDF-1, VEGF or both and that have CXCR-4-mediated chemotactic activity; wherein the therapeutic amount comprises at least 0.5 ×10 6 potent SDF-1 mobile CD34+/CXCR-4+ cells that have CXCR-4 mediated chemotactic activity and is effective to repair a vascular injury caused by vascular insufficiency in a subject in need thereof; (b) a stabilizing amount of serum, wherein the stabilizing amount of serum constitutes from about 0.1% to about 70% (v/v) of the composition, and is effective to retain the CXCR-4 mediated chemotactic activity and hematopoietic colony forming activity of the subpopulation of CD34+/CXCR-4+cells, and that move in response to SDF-1, VEGF or both; the composition being characterized as having the following properties for at least 24 hours following acquisition of the mononuclear cells when tested in vitro after passage through the catheter: (i) at least 70% of the cells in the composition are CD34+cells, (ii) the subpopulation of-potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity and that move in response to SDF-1, VEGF or both retains at least 1% of the chemotactic activity of the CXCR-4-mediated chemotactic activity of the subpopulation of potent CD34+/CXCR-4+ cells that have CXCR-4-mediated chemotactic activity; (iii) at least 70% of the cells in the composition are viable; and (iv) the CD34+cells in the composition are able to form hematopoietic colonies in vitro.