Cold storage of organotypically cultured skin equivalents for clinical applications

Abstract

The present invention relates generally to systems and methods for storing, shipping and using skin equivalents made by organotypic culture. In particular, the present invention relates to systems and methods for producing, transporting, storing and using skin equivalents produced by organotypic culture at reduced temperatures, preferably from 2-8 degrees Celsius. The methods include sterile packaging of the grafts so that the sterility and integrity of the package is maintained until the time of use for grafting purposes.

1 . A method of shipping an organotypically cultured skin equivalent to a user and using said skin equivalent in a skin grafting procedure on a human patient comprising:
 providing said organotypically cultured skin equivalent comprising dermal and epidermal layers and a sterile package comprising a gel support;   packaging said skin equivalent in a sterile package under sterile conditions so that said skin equivalent contacts said gel support;   lowering the temperature of said sterile package to 2-8 degrees Celsius;   shipping said sterile package to a user at 2-8 degrees Celsius;   storing said sterile package at the site of use at 2-8 degrees Celsius wherein the sterility and integrity of the sterile package are maintained; and   removing said organotypically cultured skin equivalent from said package and applying to a patient without an intervening culture step.   
   
   
       2 . The method of  claim 1 , wherein said organotypically cultured skin equivalent comprises NIKS cells. 
   
   
       3 . The method of  claim 1 , wherein said gel support is an agarose gel support. 
   
   
       4 . The method of  claim 1 , wherein said sterile package is heat sealable. 
   
   
       5 . The method of  claim 1 , wherein skin equivalent contacts said gel support via a permeable membrane. 
   
   
       6 . A method of shipping and storing an organotypically cultured skin equivalent for use in a skin grafting procedure comprising:
 providing said organotypically cultured skin equivalent comprising dermal and epidermal layers and a sterile package comprising a gel support;   packaging said skin equivalent in a sterile package under sterile conditions so that said skin equivalent contacts said gel support on a packaging date;   lowering the temperature of said sterile package to 2-8 degrees Celsius;   shipping said sterile package to a user at 2-8 degrees Celsius;   storing said sterile package at the site of use at 2-8 degrees Celsius wherein the sterility and integrity of the sterile package are maintained for from 8 to 15 days from said packaging date.   
   
   
       7 . The method of  claim 6 , wherein said organotypically cultured skin equivalent comprises NIKS cells. 
   
   
       8 . The method of  claim 6 , wherein said gel support is an agarose gel support. 
   
   
       9 . The method of  claim 6 , wherein said sterile package is heat sealable. 
   
   
       10 . The method of  claim 6 , wherein skin equivalent contacts said gel support via a permeable membrane. 
   
   
       11 . A method of shipping an organotypically cultured skin equivalent to a user for use in a skin grafting procedure comprising:
 providing said organotypically cultured skin equivalent comprising dermal and epidermal layers and a sterile package comprising a gel support, wherein said gel support is formed with a minimal media;   packaging said skin equivalent in a sterile package under sterile conditions so that said skin equivalent contacts said gel support;   lowering the temperature of said sterile package to 2-8 degrees Celsius;   shipping said sterile package to a user at 2-8 degrees Celsius;   storing said sterile package at the site of use 2-8 degrees Celsius wherein the sterility and integrity of the sterile package are maintained.   
   
   
       12 . The method of  claim 11 , wherein said organotypically cultured skin equivalent comprises NIKS cells. 
   
   
       13 . The method of  claim 11 , wherein said gel support is an agarose gel support. 
   
   
       14 . The method of  claim 11 , wherein said sterile package is heat sealable. 
   
   
       15 . The method of  claim 11 , wherein skin equivalent contacts said gel support via a permeable membrane. 
   
   
       16 . A kit comprising:
 a shipping chamber comprising a gel support comprising a minimal media;   a skin equivalent supported on a permeable membrane in contact with said gel support; wherein said shipping chamber is contained with a sterile pouch.   
   
   
       17 . The kit of  claim 16 , wherein said organotypically cultured skin equivalent comprises NIKS cells. 
   
   
       18 . The kit of  claim 16 , wherein said gel support is an agarose gel support. 
   
   
       19 . The kit of  claim 16 , wherein said sterile package is heat sealable. 
   
   
       20 . The kit of  claim 16 , wherein skin equivalent contacts said gel support via a permeable membrane. 
   
   
       21 . An article comprising a shipping chamber having a chamber top and a chamber bottom having a surface having thereon a gel support, said article further comprising a skin equivalent on a permeable membrane, said permeable membrane in contact with said gel support, said article further comprising extensions extending from said chamber top so that when said chamber top is placed on said chamber bottom said skin equivalent is secured against said gel support. 
   
   
       22 . The article of  claim 21 , wherein said gel support is formed with minimal media.