Methods of measuring potential for therapeutic potency and defining dosages for autologous cell therapies
Inventors
Altman, Peter • Wong Po Foo, Cheryl
Assignees
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Publication Number
US-11828757-B2
Publication Date
2023-11-28
Expiration Date
Abstract
Autologous bone marrow cells (BMC) are transplanted to a heterologous site in a patient after a sample of the patient's BMC has been tested and found to have a phenotypic profile which meets minimum criteria for transplantation. The phenotypic profile may be obtained by screening a sample of bone marrow cells (BMC) from the patient for the phenotypic profile, such as a CD profile, the phenotype profile may be assessed to determine the likelihood that the BMC will be suitable for transplantation to the heterologous tissue site without enriching particular phenotypic population(s) of the BMC.
Core Innovation
The disclosure addresses patients with chronic myocardial ischemia or heart failure of ischemic etiology by using personalized autologous bone marrow cells for transplantation to a heterologous tissue site. A cell-counter aided determination is performed to assess a phenotypic profile comprising a CD profile with concentrations of at least one of CD19+, CD34+, or CD133+ cells, and the determined individual concentrations are compared to threshold concentrations to determine suitability for transplantation without enriching particular phenotypic populations beyond cell concentration by gravity centrifugation.
Suitability is defined by meeting or exceeding threshold concentrations for the CD19+, CD34+, and/or CD133+ cell concentrations, depending on the CD profile. The treatment method uses either a blood sample from the patient or a bone marrow aspirate of BMC, and the phenotypic profile includes a CD profile comprising the concentrations of at least one of CD19+, CD34+, or CD133+ cells.
In addition to screening, the disclosure includes a treating method where a dosage of the BMC is provided when the individual concentrations meet or exceed threshold concentrations for suitability for transplantation. The dosage is provided from the bone marrow aspirate, without enriching particular phenotypic populations other than cell concentration by gravity centrifugation, and the document specifies threshold concentration values and quantitative dosage constraints.
Claims Coverage
The partial content provides two independent claims: one for screening patient suitability of autologous BMC for transplantation based on threshold CD marker concentrations, and one for treating patients by transplanting autologous BMC using dosage provided when threshold concentrations are met. Across the independent claims, the inventive features focus on cell-counter assisted CD profile measurement, meeting or exceeding threshold concentrations for CD19+, CD34+, and/or CD133+ suitability, and transplantation of autologous BMC to a heterologous tissue site without enriching phenotypic subpopulations beyond cell concentration by gravity centrifugation.
Cd profile threshold screening for autologous Bmc suitability
Determining with the aid of a cell counter whether individual concentrations of at least one of CD19+, CD34+, or CD133+ cells in a phenotypic profile of cells in a blood sample each meet or exceed threshold concentrations to identify the BMC as being suitable for transplantation to a heterologous tissue site to treat chronic myocardial ischemia or heart failure of ischemic etiology, wherein the phenotypic profile comprises a CD profile comprising the concentrations of at least one of CD19+, CD34+, or CD133+ cells and wherein autologous BMC identified as suitable are transplanted without enriching particular phenotypic population(s) of the autologous BMC other than cell concentration by gravity centrifugation.
Treatment by transplanting dosage based on cd profile threshold concentrations
Determining with the aid of a cell counter individual concentrations of at least one of CD19+, CD34+, or CD133+ cells in a phenotypic profile of bone marrow cells in an aspirate or cells in a blood sample; providing a dosage of the BMC if the determined individual concentrations meet or exceed threshold concentrations for being suitable for transplantation to the heterologous tissue of the patient without enriching particular phenotypic populations of the BMC other than cell concentration by gravity centrifugation; and transplanting the dosage to the heterologous tissue site to treat chronic myocardial ischemia or heart failure of ischemic etiology.
Overall, the claim coverage centers on screening and treating chronic myocardial ischemia or ischemic heart failure using a cell-counter based CD profile with CD19+, CD34+, and/or CD133+ concentrations compared to threshold concentrations. Identified suitability supports transplantation of autologous BMC to a heterologous tissue site without enriching phenotypic subpopulations beyond cell concentration by gravity centrifugation, with the treating claim additionally tying threshold-meeting CD profiles to providing a BMC dosage from the bone marrow aspirate.
Stated Advantages
Identifies autologous BMC as suitable for transplantation without enriching particular phenotypic populations of the BMC other than cell concentration by gravity centrifugation.
Enables a likelihood that the patient’s autologous BMC will be suitable for transplantation to a heterologous tissue site to treat chronic myocardial ischemia or heart failure of ischemic etiology.
Documented Applications
Screening patients with chronic myocardial ischemia or heart failure of ischemic etiology to determine a likelihood that their autologous bone marrow cells will be suitable for transplantation to a heterologous tissue site.
Treating patients with chronic myocardial ischemia or heart failure of ischemic etiology by transplanting the patient’s autologous BMC to a heterologous tissue site.
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