US2015118199A1PendingUtilityA1

Methods of measuring potential for therapeutic potency and defining dosages for autologous cell therapies

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Assignee: BIOCARDIA INCPriority: Oct 28, 2013Filed: Oct 28, 2014Published: Apr 30, 2015
Est. expiryOct 28, 2033(~7.3 yrs left)· nominal 20-yr term from priority
Inventors:Peter A. AltmanCheryl Wong Po Foo
A61K 35/28G01N 33/56966G01N 2800/52G01N 2333/70596
67
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Claims

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for screening a patient to determine a likelihood that the patient's autologous bone marrow cells will be suitable for transplantation to a heterologous tissue site, said method comprising
 providing a sample of bone marrow cells (BMC) from the patient;   obtaining a phenotypic profile of the BMC in the sample; and   assessing the phenotype profile 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.   
     
     
         2 . A method as in  claim 1 , wherein the phenotypic profile is a CD profile. 
     
     
         3 . A method as in  claim 2 , wherein the CD profile includes the concentration of cells having at least two CD markers in the sample. 
     
     
         4 . A method as in  claim 3 , wherein the CD profile includes the concentration of cells having at least three CD markers in the sample. 
     
     
         5 . A method as in  claim 3 , wherein the at least two CD markers are selected from the group consisting of CD19, CD34, and CD133. 
     
     
         6 . A method as in  claim 5 , wherein the at least two CD markers include CD34 and CD 133. 
     
     
         7 . A method as in  claim 4 , wherein the at least three CD markers include CD19, CD34, and CD133. 
     
     
         8 . A method as in  claim 6 , wherein a sample having at least 27,100CD34 +  cells/ml and at least 12,100 CD133 +  cells/ml is considered suitable for heterologous transplantation. 
     
     
         9 . A method as in  claim 7 , wherein a sample having at least 24,000 CD19 +  cells/ml, at least 27,100 CD34 +  cells/ml, and at least 12,100 CD133 +  cells/ml is considered suitable for heterologous transplantation. 
     
     
         10 . A method as in  claim 1 , wherein assessing comprises flow cytometry. 
     
     
         11 . A method for transplanting a patient's autologous bone marrow cells to the patient, said method comprising:
 transplanting the autologous bone marrow cells (BMC) to a heterologous site in the patient, wherein a sample of the patient's BMC has previously been tested and found to have a phenotypic profile which meets a minimum criteria for transplantation.   
     
     
         12 . A method as in  claim 11 , wherein the BMC are transplanted without isolation or enrichment based on phenotype. 
     
     
         13 . A method as in  claim 11 , wherein the BMC are transplanted without isolation or enrichment based on the presence of particular CD antigens. 
     
     
         14 . A method as in  claim 11 , wherein the BMC are transplanted into cardiac tissue. 
     
     
         15 . A method as in  claim 14 , wherein the BMC are enriched without regard to phenotype before transplantation. 
     
     
         16 . A method as in  claim 14 , wherein the cardiac tissue is infarcted. 
     
     
         17 . A method as in  claim 16 , wherein transplanting comprises intra-myocardial injection into a region of infarcted tissue. 
     
     
         18 . A method as in  claim 16 , wherein the BMC are injected with a helical needle. 
     
     
         19 . A method as in  claim 16 , wherein at least 72,600 CD133 +  cells are present in the infarcted tissue one hour after transplantation. 
     
     
         20 . A method as in  claim 16 , wherein at least 162,600 CD34 +  cells are present in the infarcted tissue one hour after transplantation. 
     
     
         21 . A method as in  claim 16 , wherein at least 144,000 CD19 +  cells are present in the infarcted tissue one hour after transplantation. 
     
     
         22 . A method as in  claim 17 , wherein at least 72,600 CD133 +  cells, at least 162,600 CD34 +  cells, and at least 144,000 CD19 +  cells are present in the infarcted tissue one hour after transplantation. 
     
     
         23 . A method as in  claim 11 , wherein a pre-procedure biopsy of the patient has a therapeutic threshold of greater than 162,600 CD34 +  cells/ml of aspirate and a therapeutic dosage in the range from 1 cc to 10 cc is concentrated and delivered to the heart using a catheter system that has at least 18% retention one hour after delivery on average. 
     
     
         24 . A method as in  claim 11 , wherein a pre-procedure biopsy of the patient has a therapeutic threshold of greater than 72,600 CD133 +  cells/ml of aspirate and a therapeutic dosage in the range from 1 cc to 10 cc is concentrated and delivered to the heart using a catheter system that has at least 18% retention one hour after delivery on average. 
     
     
         25 . A method as in  claim 11 , wherein a pre-procedure biopsy of the patient has a therapeutic threshold of greater than 144,000 CD19 +  cells/ml of aspirate and a therapeutic dosage in the range from 1 cc to 10 cc is concentrated and delivered to the heart using a catheter system that has at least 18% retention one hour after delivery on average. 
     
     
         26 . A method as in  claim 11 , wherein a pre-procedure biopsy of the patient has a therapeutic threshold of greater than 162,600 CD34 +  cells/ml, 72,600 CD133 +  cells/ml, and 144,000 CD19 +  cells/ml of aspirate and a therapeutic dosage in the range from 1 cc to 10 cc is concentrated and delivered to the heart using a catheter system that has at least 18% retention one hour after delivery on average. 
     
     
         27 . A method as in  claim 11 , wherein the phenotype profile is a CD profile. 
     
     
         28 . A method as in  claim 27 , wherein the CD profile includes the concentration of cells having at least two CD markers in the sample. 
     
     
         29 . A method as in  claim 28 , wherein the CD profile includes the concentration of cells having at least three CD markers in the sample. 
     
     
         30 . A method as in  claim 29 , wherein the at least two CD markers are selected from the group consisting of CD19, CD34, and CD133. 
     
     
         31 . A method as in  claim 30 , wherein the at least two CD markers are CD34 and CD33. 
     
     
         32 . A method as in  claim 30 , wherein the at least three CD markers are CD19, CD34, and CD 133. 
     
     
         33 . A method as in  claim 32 , wherein a sample having at least 38,500 CD34 +  cells/ml and at least 6,500 CD133 +  cells/ml is considered suitable for heterologous transplantation. 
     
     
         34 . A method as in  claim 33 , wherein a sample having at least 13,000 CD19 +  cells/ml, at least 38,500 CD34 +  cells/ml, and at least 6,500 CD133 +  cells/ml is considered suitable for heterologous transplantation. 
     
     
         35 . A method as in  claim 11 , wherein the cells are assessed by flow cytometry. 
     
     
         36 . A method as in  claim 11 , wherein a final dosage of at least 100 million BMC is transplanted to the patient. 
     
     
         37 . An antibody panel comprising
 a first antibody or other substance which specifically binds to a first bone marrow cell (BMC) marker; and   a second antibody or other substance which specifically binds to a second bone marrow cell (BMC) marker;   wherein the first and second markers are characteristic of the suitability of the BMC for transplantation to a heterologous tissue site in the patient.   
     
     
         38 . A panel as in  claim 37 , wherein the at least two antibodies are specific for CD markers selected from the group consisting of CD19, CD34, and CD133. 
     
     
         39 . A panel as in  claim 38 , wherein the at least two CD markers are CD34 and CD133. 
     
     
         40 . A panel as in  claim 37 , wherein the antibodies are specific for at least three CD markers including CD19, CD34, and CD 133. 
     
     
         41 . A panel as in  claim 37 , wherein antibodies or other substances are suitable for use in flow cytometry.

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