Rapid infusion of autologous bone marrow derived stem cells
First Claim
1. A point-of-care method of ameliorating critical limb ischemia or a condition associated with critical limb ischemia in a subject comprising:
- identifying a subject having a critical limb ischemia or a condition associated with critical limb ischemia;
providing to said subject a composition comprising;
(a) a first cell population that comprises CD34+ and CD34−
bone marrow stem cells,(b) an anticoagulant, and(c) an aqueous buffer and/or an autologous serum and/or an autologous plasma fraction,wherein the composition has a viscosity of 1.5 to 5.0 centipoise (cP) measured at 37°
C. and wherein said composition is provided to said subject at a rate of 1.0 mL per minute.
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Accused Products
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.
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Citations
49 Claims
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1. A point-of-care method of ameliorating critical limb ischemia or a condition associated with critical limb ischemia in a subject comprising:
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identifying a subject having a critical limb ischemia or a condition associated with critical limb ischemia; providing to said subject a composition comprising; (a) a first cell population that comprises CD34+ and CD34−
bone marrow stem cells,(b) an anticoagulant, and (c) an aqueous buffer and/or an autologous serum and/or an autologous plasma fraction, wherein the composition has a viscosity of 1.5 to 5.0 centipoise (cP) measured at 37°
C. and wherein said composition is provided to said subject at a rate of 1.0 mL per minute. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A point-of-care method of ameliorating critical limb ischemia or a condition associated with critical limb ischemia in a subject comprising:
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identifying a subject having a critical limb ischemia or a condition associated with critical limb ischemia; introducing bone marrow aspirate from said subject into a bone marrow processing system; isolating a stem cell fraction, a plasma fraction, and a red blood cell fraction from said disposable bone marrow processing device; adding plasma from said plasma fraction and red blood cells from said red blood cell fraction to said stem cell fraction to obtain a composition with a viscosity of 1.5 to 5.0 centipoise(cP) measured at 37°
C.; andproviding said composition with a viscosity of 1.5 to 5.0 centipoise (cP) measured at 37°
C. to said subject. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A point-of-care method of ameliorating critical limb ischemia or a condition associated with critical limb ischemia in a subject comprising:
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identifying a subject having a critical limb ischemia or a condition associated with critical limb ischemia; introducing bone marrow aspirate from said subject into a bone marrow processing system that comprises; (a) a sterile, disposable bone marrow processing device, (b) a control module comprising a gravitational sensor and an infra-red optical sensor coupled with a microprocessor and motor, which are configured to control the flow, movement, and compartmentalization of separated fractions of bone marrow aspirate, (c) a docking station that transfers processing data from the control module to a computer, and (d) a centrifuge; isolating a stem cell fraction, a plasma fraction, and a red blood cell fraction from said disposable bone marrow processing device; adding plasma from said plasma fraction and red blood cells from said red blood cell fraction to said stem cell fraction to obtain a composition with a viscosity of 1.5 to 5.0 centipoise (cP) measured at 37°
C; andproviding said composition with a viscosity of 1.5 to 5.0 centipoise (cP) measured at 37°
C. to said subject. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49)
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Specification