Collagen/glycosaminoglycan compositions for use as terminally sterilizable matrices

Abstract

Compositions of cross-linked collagen and a glycosaminoglycan are provided which retain characteristics rendering them useful as tissue engineering matrices or scaffolds following terminal sterilization. Also provided are methods for producing these compositions and terminally sterilized matrices or scaffolds from these compositions as well as methods of using these matrices or scaffolds as tissue engineering devices.

1 . A composition comprising cross-linked collagen a glycosaminoglycan, said composition retaining characteristics to function as a matrix or scaffold following terminal sterilization.  
     
     
         2 . The composition of  claim 1  further comprising a silicone layer applied to the collagen and glycosaminoglycan prior to cross-linking.  
     
     
         3 . A terminally sterilized matrix or scaffold comprising the composition of  claim 1 .  
     
     
         4 . A terminally sterilized matrix or scaffold comprising the composition of  claim 2 .  
     
     
         5 . A method for producing the composition of  claim 1  comprising cross-linking the collagen and glycosaminoglycan at a density which stabilizes the composition toward electron beam radiation while retaining characteristics of the composition to function as a matrix or scaffold.  
     
     
         6 . The method of  claim 5  wherein cross-linking of the composition is performed with glutaraldehyde at a concentration greater than 0.25%.  
     
     
         7 . The method of  claim 5  wherein the composition is subjected to two or more cross-linking steps.  
     
     
         8 . The method of  claim 7  wherein the two or more cross-linking steps are performed with glutaraldehyde at 0.25%.  
     
     
         9 . A method for producing a terminally sterilized matrix or scaffold comprising: 
 (a) producing a composition of  claim 1;     (b) sealing the composition in a package; and    (c) exposing the composition in the sealed package to electron beam radiation.    
     
     
         10 . The method of  claim 9  wherein the composition of step (a) is produced by cross-linking the collagen and glycosaminoglycan at a density which stabilizes the composition toward electron beam radiation while retaining characteristics of the composition to function as a matrix or scaffold.  
     
     
         11 . A terminally sterilized matrix or scaffold produced in accordance with the method of  claim 9 .  
     
     
         12 . A method for regenerating dermal or sub-dermal tissue in a subject comprising applying to or implanting within the subject the terminally sterilized matrix or scaffold of  claim 3  at or near an excision site of dermal or subdermal tissue or a site where augmentation of dermal or subdermal tissue is required.