Graft materials containing bioactive extracellular matrices and cells

Abstract

Described are packaged, sterile medical graft products containing controlled levels of a growth factor such as Fibroblast Growth Factor-2 (FGF-2). Also described are methods of manufacturing medical graft products wherein processing, including sterilization, is controlled and monitored to provide medical graft products having modulated, known levels of a extracellular matrix factor, such as a growth factor, e.g. FGF-2. Preferred graft materials are extracellular matrix materials isolated from human or animal donors, particularly submucosa-containing extracellular matrix materials. Further described are ECM compositions that are or are useful for preparing gels, and related methods for preparation and use.

1 - 105 . (canceled) 
     
     
         106 . A composition, comprising a decellularized extracellular matrix material comprising extractable, bioactive native Fibroblast Growth Factor-2 at a level of at least 50 ng per gram dry weight, and added cells. 
     
     
         107 . The composition of  claim 106 , wherein the cells comprise human dermal fibroblasts or human bladder smooth muscle cells. 
     
     
         108 . The composition of  claim 106 , wherein the extracellular matrix material is in a gel. 
     
     
         109 . A method for culturing cells, comprising culturing the cells in the presence of a decellularized extracellular matrix material comprising extractable, bioactive Fibroblast Growth Factor-2 at a level of at least about 50 ng/g dry weight. 
     
     
         110 . The method of  claim 109 , wherein the extracellular matrix material is in particulate form. 
     
     
         111 . A method for preparing a medical material comprising providing a decellularized extracellular matrix material comprising extractable, bioactive Fibroblast Growth Factor-2 at a level of at least about 50 ng/g dry weight, and adding cells to the extracellular matrix material. 
     
     
         112 . A composition comprising an extracellular matrix hydrolysate having a native FGF-2 level of about 100 ng to about 500 ng per gram dry weight of the extracellular matrix hydrolysate, and added cells. 
     
     
         113 . The composition of  claim 112 , wherein the extracellular matrix hydrolysate is in a gel. 
     
     
         114 . The composition of  claim 112 , wherein the extracellular matrix hydrolysate is a dried powder. 
     
     
         115 . The composition of  claim 112 , wherein the extracellular matrix hydrolysate is in a non-gelled aqueous medium.