Amnion-derived cell compositions, methods of making and uses thereof

Abstract

The invention is directed to substantially purified amnion-derived cell populations, compositions comprising the substantially purified amnion-derived cell populations, and to methods of creating such substantially purified amnion-derived cell populations, as well as methods of use. The invention is further directed to antibodies, in particular, monoclonal antibodies, that bind to amnion-derived cells or, alternatively, to one or more amnion-derived cell surface protein markers. The invention is further directed to methods for producing the antibodies, methods for using the antibodies, and kits comprising the antibodies.

1 - 55 . (canceled) 
     
     
         56 . A composition comprising cell lysate, wherein the cell lysate is obtained by lysing a substantially purified population of cultured amnion-derived epithelial cells made by the method of
 a) obtaining a placenta and isolating an amnion from the placenta,   b) enzymatically releasing amnion-derived epithelial cells from the amnion,   c) collecting the released amnion-derived epithelial cells, and   d) culturing the collected amnion-derived epithelial cells of step (c) in basal culture medium that is supplemented with human serum albumin and recombinant human EGF.   
     
     
         57 . The composition of  claim 56  wherein the basal medium is IMDM. 
     
     
         58 . The composition of  claim 57  wherein the IMDM is supplemented with 0.5% human serum albumin. 
     
     
         59 . The composition of  claim 56  wherein the recombinant human EGF is at a concentration of 10 ng/mL in the culture medium. 
     
     
         60 . The composition of  claim 56  wherein the basal medium and all media supplements are free of xeno-contamination. 
     
     
         61 . The composition of  claim 56  wherein the collected cells of step c) are negative for expression of the protein markers CD90, CD117 and CD105. 
     
     
         62 . A pharmaceutical composition comprising the cell lysate composition of  claim 56 . 
     
     
         63 . The composition of  claim 61 , wherein the collected cells in step c) are further negative for telomerase expression.