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 of 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 . (canceled) 
     
     
         7 . The cytotherapeutic unit of  claim 1  wherein said potent cells are obtained from placenta. 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . The cytotherapeutic unit of  claim 1  wherein potent cells for which the identities and numbers are known comprise at least some of the cells exhibiting CD34, CD8, CD10, 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 . (canceled) 
     
     
         14 . The cytotherapeutic unit of  claim 1  wherein potent cells are genetically modified. 
     
     
         15 . (canceled) 
     
     
         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 . (canceled) 
     
     
         18 . A cytotherapeutic unit comprising minimum numbers of preselected types of potent cells. 
     
     
         19 - 25 . (canceled) 
     
     
         26 . A kit for treatment of a person suspected of having a disease state or condition comprising the cytotherapeutic unit of  claim 1 , additionally comprising a certification of the accuracy of the assay. 
     
     
         27 . (canceled) 
     
     
         28 . A kit for treatment of a person suspected of having a disease state or condition comprising the cytotherapeutic unit of  claim 18 , additionally comprising a certification of the potent cell composition of the unit. 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . The cytotherapeutic unit of  claim 18 , 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 . (canceled) 
     
     
         33 . (canceled) 
     
     
         34 . The cytotherapeutic unit of  claim 18 , 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 . (canceled) 
     
     
         37 . (canceled) 
     
     
         38 . (canceled) 
     
     
         39 . A method of treating a disease in a mammal comprising administering to said mammal a therapeutically effective amount of a composition comprising the cytotherapeutic unit of  claim 1 . 
     
     
         40 - 49 . (canceled) 
     
     
         50 . A library of cytotherapeutic units, each unit member of said library comprising a plurality of potent cells; the content of each 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 the library of cytotherapeutic units of  claim 50  at least two unit members of said library; combing aliquots from said unit members to form a treatment unit and administering said treatment unit to the patient. 
     
     
         52 . (canceled) 
     
     
         53 . (canceled)