Cytotherapeutics, Cytotherapeutic Units and Methods for Treatments Using Them

Abstract

The present invention provides cytotherapeutic units comprising predetermined numbers of selected types of potent cells. Assurance of the nature and identities of such cells is achieved through assay and certification of said numbers and identities. Therapeutic modalities are provided. Libraries of cell preparations with assayed and preferably certified populations are preferred and the preparation of cell preparations tailored to specific patients or disease states are provided.

1 . A cytotherapeutic unit comprising a plurality of potent cells; the content of said unit being known with respect to the identities and numbers at least some of said plurality; the unit being assayed to ensure the accuracy of said identities and numbers. 
     
     
         2 . The cytotherapeutic unit of  claim 1  wherein the accuracy of the assay is certified by the provider of the unit. 
     
     
         3 . The cytotherapeutic unit of  claim 1  wherein the potent cells for which the identities and numbers are known are pluripotent cells. 
     
     
         4 . The cytotherapeutic unit of  claim 1  wherein said identities reflect the presence or absence of at least one antigenic determinant on identified cells. 
     
     
         5 . The cytotherapeutic unit of  claim 1  wherein said potent cells are obtained from fetal cord blood or other fetal tissue. 
     
     
         6 . The cytotherapeutic unit of  claim 1  wherein said potent cells are obtained from fetal cord blood. 
     
     
         7 . The cytotherapeutic unit of  claim 1  wherein said potent cells are obtained from placenta. 
     
     
         8 . The cytotherapeutic unit of  claim 1  wherein said potent cells are obtained from postpartum placenta. 
     
     
         9 . The cytotherapeutic unit of  claim 1  wherein said potent cells are obtained from postpartum placenta perfusate. 
     
     
         10 . The cytotherapeutic unit of  claim 1  wherein potent cells for which the identities and numbers are known comprise at least some of cells exhibiting CD34, CD8, CD 10, OCT4. 
     
     
         11 . The cytotherapeutic unit of  claim 1  wherein potent cells are derived from a plurality of sources. 
     
     
         12 . The cytotherapeutic unit of  claim 1  wherein potent cells are derived from at least two individuals. 
     
     
         13 . The cytotherapeutic unit of  claim 1  wherein potent cells are derived from at least 5 individuals 
     
     
         14 . The cytotherapeutic unit of  claim 1  wherein potent cells are genetically modified. 
     
     
         15 . The cytotherapeutic unit of  claim 1  wherein at least one type of cell is excluded from the unit. 
     
     
         16 . The cytotherapeutic unit of  claim 1  wherein the plurality of potent cells is selected to render the cytotherapeutic unit suitable for therapy for an indicated disease state or condition. 
     
     
         17 . The cytotherapeutic unit of  claim 16  wherein at least one type of cell is excluded from the unit. 
     
     
         18 . A cytotherapeutic unit comprising minimum numbers of preselected types of potent cells. 
     
     
         19 . The cytotherapeutic unit of  claim 18  which has been assayed to ensure accuracy of its contents of preselected types of potent cells. 
     
     
         20 . The cytotherapeutic unit of  claim 18  wherein the contents of preselected potent cells is certified. 
     
     
         21 . The cytotherapeutic unit of  claim 18  wherein at least one type of cell is excluded from the unit. 
     
     
         22 . The cytotherapeutic unit of  claim 21  wherein the contents of preselected potent cells and the absence the types of cells to be excluded is certified. 
     
     
         23 . The cytotherapeutic unit of  claim 18 , wherein said certification is of a plurality of potent cell types, said plurality and the numbers of each of said plurality being selected to render the cytotherapeutic unit suitable for therapy for an indicated disease state or condition. 
     
     
         24 . The cytotherapeutic unit of  claim 23 , wherein said certification is of a plurality of potent cell types, said plurality and the numbers of each of said plurality being selected as well as the types of cells excluded renders the cytotherapeutic unit suitable for therapy for an indicated disease state or condition. 
     
     
         25 . The cytotherapeutic unit of  claim 18  where at least some potent cells are genetically modified. 
     
     
         26 . A kit for treatment of a person suspected of having a disease state or condition comprising a cytotherapeutic unit comprising a plurality of potent cells; the content of said unit being known with respect to the identities and numbers at least some of said plurality; the unit being assayed to ensure the accuracy of said identities and numbers; and a certification of the accuracy of the assay. 
     
     
         27 . The kit of  claim 26  wherein at least one type of cell has been excluded from the cytotherapeutic unit. 
     
     
         28 . A kit for treatment of a person suspected of having a disease state or condition comprising a cytotherapeutic unit having minimum numbers of identified potent cells and a certification of the potent cell composition of the unit. 
     
     
         29 . The kit of  claim 28  wherein at least one type of cell has been excluded from the cytotherapeutic unit. 
     
     
         30 . The kit of  claim 28  wherein at least some cells are genetically modified. 
     
     
         31 . A cytotherapeutic unit comprising cells derived from umbilical cord blood, placenta, or a mixture thereof, wherein at least one type of cell has been removed from the unit. 
     
     
         32 . The cytotherapeutic unit of  claim 31  wherein a plurality of cell types have been removed from the unit. 
     
     
         33 . The cytotherapeutic unit of  claim 31  wherein at least some cells of the unit are genetically modified. 
     
     
         34 . A cytotherapeutic unit comprising cells derived from umbilical cord blood, placenta, or a mixture thereof, said cells comprising a plurality of different types, at least some of the different types having been separated into components and recombined into said unit. 
     
     
         35 . The cytotherapeutic unit of  claim 34 , wherein said separated cell types have been frozen separately. 
     
     
         36 . The cytotherapeutic unit of  claim 34 , in a frozen state. 
     
     
         37 . The cytotherapeutic unit of  claim 34 , wherein said separated cell types have been characterized. 
     
     
         38 . The cytotherapeutic unit of  claim 34 , wherein said separated cell types have been genetically modified 
     
     
         39 . A method of treating a disease in a mammal comprising:
 Administering to said mammal a therapeutically effective amount of a composition comprising: a cytotherapeutic unit comprising a plurality of potent cells; the content of said unit being known with respect to the identities and numbers of at least some of said plurality; the unit being assayed to ensure the accuracy of said identities and numbers.   
     
     
         40 . The method of  claim 39 , wherein the cytotherapeutic unit comprises minimum numbers of preselected types of potent cells. 
     
     
         41 . The method of  claim 39 , wherein the accuracy of said identities and numbers is certified. 
     
     
         42 . The method of  claim 39 , wherein the cytotherapeutic unit is derived from post-partum placenta. 
     
     
         43 . The method of  claim 39 , wherein the cytotherapeutic unit is derived from post-partum placenta perfusate. 
     
     
         44 . The method of  claim 39 , wherein said unit comprises at least one cell that is autologous. 
     
     
         45 . The method of  claim 39 , wherein said unit comprises at least one cell that is exogenous. 
     
     
         46 . The method of  claim 39 , wherein said unit is administered multiple times. 
     
     
         47 . The method of  claim 39 , wherein said method further comprises administering multiples of said units that are derived from different individuals. 
     
     
         48 . The method of  claim 39 , wherein said method further comprises administering multiples of said units that are derived from different sources. 
     
     
         49 . The method of  claim 39 , wherein said method further comprises administering multiple units that are genetically modified. 
     
     
         50 . A library of cytotherapeutic units, each unit member of said library comprising a plurality of potent cells; the content of each of said units being known with respect to the identities and numbers at least some of the plurality of potent cells comprising said unit; each of said units being assayed to ensure the accuracy of said identities and numbers. 
     
     
         51 . A method of treatment of a patient in need of cytotherapeutic treatment comprising selecting from a library of cytotherapeutic units at least two unit members of said library; combining aliquots from said unit members to form a treatment unit and administering said treatment unit to the patient. 
     
     
         52 . The method of  claim 51  wherein each of the unit members of the library has been assayed to determine the identity and numbers of potent cells present in said unit member. 
     
     
         53 . The method of  claim 51  wherein at least one of said unit members of the library has been reduced in at least one selected cell population.