Rapid infusion of autologous bone marrow derived stem cells
Inventors
Harris, Kenneth • Sethi, Dalip • Ponemone, Venkatesh • Cohan, Gary R.
Assignees
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Publication Number
US-9439930-B2
Publication Date
2016-09-13
Expiration Date
Abstract
The present invention relates to a method and composition for the aspiration, processing, testing and infusion of bone marrow derived stem cells, as an adjuvant treatment in cardiovascular disorders. More specifically, the invention provides for the methods and compositions for the aspiration, analysis, processing, infusate preparation and infusion of bone-marrow derived stem cells, particularly in a rapid point-of-care environment, wherein a centrifugal fractionation and optically monitored separation of the bone marrow yield desired cellular product in the desired concentration and viscosity.
Core Innovation
The invention provides a composition comprising a first cell population that comprises bone marrow stem cells and/or progenitor cells, an anticoagulant, an aqueous buffer and/or an autologous serum and/or an autologous plasma fraction, and red blood cells, where the composition has a viscosity of 1.5-3.5 centipoise (cP) measured at 37°C. The disclosed compositions include formulations that can contain mononuclear cells, red blood cells, and autologous serum/plasma fractions together with the cell population and anticoagulant.
The disclosed process enriches bone marrow stem cells within the composition comprising the cell population and the anticoagulant, isolates a fraction comprising the enriched bone marrow stem cells and/or progenitor cells, and adjusts the viscosity of the fraction using red blood cells to a viscosity of 1.5 cP-5.0 cP measured at 37°C so as to make the regenerative cell composition. The cell populations include enriched bone marrow stem cells and/or progenitor cells and can include hematopoietic stem cells, mesenchymal stem cells, endothelial progenitor cells, and CXCR4-positive cells.
The invention further characterizes the regenerative cell composition by defining viscosity measured at 37°C and by including constraints related to post-delivery apoptosis or other cell death rate. In certain described refinements, the apoptosis or other cell death rate is no more than about 40% one hour after delivery under specified catheter, flow rate, and syringe pressure/plunger force conditions, and in some embodiments is also constrained by a maximum shear of not more than 9101/second.
Claims Coverage
The partial content includes three independent claims covering a composition and formulation properties, a method of making the regenerative cell composition, and a process defining a composition made by that process. Across these independent claims, the main inventive features are centered on a defined viscosity at 37°C using red blood cells, inclusion of an anticoagulant with bone marrow stem/progenitor cells, enrichment and fraction isolation, and refinements including apoptosis/cell-death constraints and delivery shear constraints.
Viscosity-defined regenerative cell composition at 37°C
A composition comprising a first cell population that comprises bone marrow stem cells and/or progenitor cells, an anticoagulant, an aqueous buffer and/or an autologous serum and/or an autologous plasma fraction, and red blood cells, wherein the composition has a viscosity of 1.5-3.5 centipoise (cP) measured at 37°C.
Regenerative cell composition made by enrichment and red-blood viscosity adjustment
A method of making a regenerative cell composition comprising providing a first cell population that comprises bone marrow stem cells and/or progenitor cells; mixing an anticoagulant with said first cell population; enriching bone marrow stem cells within the composition to produce a second cell population that comprises enriched bone marrow stem cells and/or progenitor cells; isolating a fraction comprising said second cell population; and adjusting the viscosity of said fraction using red blood cells to a viscosity of 1.5 cP-5.0 cP measured at 37°C.
Regenerative cell composition made by process including viscosity adjustment using red blood
A regenerative cell composition made by a process comprising providing a first cell population that comprises bone marrow stem cells and/or progenitor cells; mixing an anticoagulant with said first cell population; enriching bone marrow stem cells within the composition to produce a second cell population that comprises enriched bone marrow stem cells and/or progenitor cells; isolating a fraction comprising said second cell population; and adjusting the viscosity of said fraction using red blood cells to a viscosity of 1.5 cP-5.0 cP measured at 37°C.
The independent claims collectively cover a viscosity-defined regenerative cell composition at 37°C, and methods/processes that mix an anticoagulant with bone marrow stem/progenitor cells, enrich and isolate an enriched fraction, and adjust viscosity using red blood cells to a specified range measured at 37°C.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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