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-9402867-B2
Publication Date
2016-08-02
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 point-of-care method of ameliorating ischemia or a condition associated with ischemia in a subject. The method identifies a subject having an ischemia or a condition associated with ischemia and provides a composition comprising a first cell population that comprises CD34+ and CD34− bone marrow stem cells, an anticoagulant, and autologous plasma, where the composition has a viscosity of 1.5 to 5.0 centipoise (cP) measured at 37° C. The composition is provided to the subject at a defined rate.
The invention includes processing subject bone marrow aspirate in a point-of-care bone marrow processing system to isolate multiple fractions. A stem cell fraction, a plasma fraction, and a red blood cell fraction are isolated, and plasma from the plasma fraction and red blood cells from the red blood cell fraction are added to the stem cell fraction to obtain a composition with a viscosity of 1.5 to 5.0 centipoise (cP) measured at 37° C., which is then provided to the subject.
In described implementations, the processing system comprises a sterile, disposable bone marrow processing device including a control module with sensors and a microprocessor, a docking station transferring processing data, and a centrifuge. The composition can be provided using catheter delivery, including a catheter having a lumen size of approximately 0.36 mm, and can include blocking blood flow to ischemic tissue using an inflatable balloon configured to block at least 80% of blood flow distal to the balloon.
Claims Coverage
The partial content includes three independent claims. Each independent claim is centered on point-of-care amelioration of ischemia using viscosity-controlled cell/plasma compositions, with claim-specific constraints on cell composition, fraction isolation and mixing, and processing device architecture.
Viscosity-controlled autologous plasma stem cell composition with defined administration rate
A point-of-care method of ameliorating ischemia or a condition associated with ischemia in a subject by identifying a subject having an ischemia or a condition associated with ischemia and providing a composition comprising a first cell population that comprises CD34+ and CD34− bone marrow stem cells, an anticoagulant, and autologous plasma, wherein the composition has a viscosity of 1.5 to 5.0 centipoise (cP) measured at 37° C. and is provided to the subject at a defined rate.
Fractionating bone marrow aspirate into stem, plasma, and red blood cell fractions and recombining to a viscosity-defined composition
A point-of-care method of ameliorating ischemia or a condition associated with ischemia in a subject by introducing bone marrow aspirate from the subject into a bone marrow processing system, isolating a stem cell fraction, a plasma fraction, and a red blood cell fraction, adding plasma from the plasma fraction and red blood cells from the red blood cell fraction to the stem cell fraction to obtain a composition with a viscosity of 1.5 to 5.0 centipoise (cP) measured at 37° C., and providing the composition with that viscosity to the subject.
Disposable bone marrow processing device with control module sensors and centrifuge to prepare viscosity-defined stem/plasma/red blood cell composition
A point-of-care method of ameliorating ischemia or a condition associated with ischemia in a subject by introducing bone marrow aspirate into a bone marrow processing system comprising a sterile, disposable bone marrow processing device, a control module comprising sensors and a microprocessor, a docking station transferring processing data to a computer, and a centrifuge, isolating a stem cell fraction, a plasma fraction, and a red blood cell fraction from the disposable bone marrow processing device, adding plasma from the plasma fraction and red blood cells from the red blood cell fraction to the stem cell fraction to obtain a composition with a viscosity of 1.5 to 5.0 centipoise (cP) measured at 37° C., and providing the composition with that viscosity to the subject.
Across the independent claims, the core coverage is point-of-care amelioration of ischemia using a composition prepared to a defined viscosity at 37° C. and containing bone-marrow-derived stem cell populations and autologous plasma, with additional claim coverage for isolating stem, plasma, and red blood cell fractions and, in one independent claim, preparing the composition using a disposable processing device architecture including a control module, a docking station, and a centrifuge.
Stated Advantages
Improved left ventricle ejection fraction (LVEF) (reported as ~4-fold vs conventional; an example improved 36% to 60.3% by 24 months).
Improved critical limb ischemia outcome (reported amputation-free survival ~82.35% at 12 months).
Improved collateral vessel number/size in critical limb ischemia.
Safety observations reported in cited examples, including no major adverse cardiac events in the cited AMI example and no serious therapy-related adverse events in the described limb ischemia study.
Documented Applications
Point-of-care treatment intended to ameliorate ischemic cardiovascular conditions, including ischemic heart indications such as acute myocardial infarction (AMI).
Point-of-care treatment intended to ameliorate ischemic limb conditions, including critical limb ischemia (CLI), with referenced limb ischemia clinical study context.
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