Cold storage of organotypically cultured skin equivalents for clinical applications
View Patent ↗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 kit comprising: a shipping chamber comprising a gel support comprising a minimal media; an organotypically cultured skin equivalent supported on a permeable membrane in contact with said gel support; wherein said shipping chamber is contained with a sealed, sterile pouch and lacks any liquid on its packaging date.
2. The kit of claim 1 , wherein said organotypically cultured skin equivalent comprises NIKS cells.
3. The kit of claim 1 , wherein said gel support is an agarose gel support.
4. The kit of claim 1 , wherein said sterile pouch is heat sealable.
5. The kit of claim 1 , wherein said skin equivalent contacts said gel support via said permeable membrane.
6. The kit of claim 1 , wherein said organotypically cultured skin equivalent comprises NIKS cells.
7. The kit of claim 1 , wherein said organotypically cultured skin equivalent, on the packaging date of the chamber and after storage of the packaged chamber for 8 days at 2-8 degrees Celsius, has an initial barrier function value of ≤294 DPM and a second barrier function value of ≤658 DPM, when the second barrier function value is measured 10 seconds after the initial barrier function value.
8. The kit of claim 7 , wherein said organotypically cultured skin equivalent comprises NIKS cells.
9. The kit of claim 1 , wherein said organotypically cultured skin equivalent, on the packaging date of the chamber and after storage of the packaged chamber for 15 days at 2-8 degrees Celsius, has an initial barrier function value of ≤294 DPM and a second barrier function value of ≤658 DPM, when the second barrier function value is measured 10 seconds after the initial barrier function value.
10. The kit of claim 9 , wherein said organotypically cultured skin equivalent comprises NIKS cells.
11. The kit of claim 1 , wherein said organotypically cultured skin equivalent, on the packaging date of the chamber and after storage of the packaged chamber for 25 days at 2-8 degrees Celsius, has an initial barrier function value of ≤294 DPM and a second barrier function value of ≤658 DPM, when the second barrier function value is measured 10 seconds after the initial barrier function value.
12. The kit of claim 11 , wherein said organotypically cultured skin equivalent comprises NIKS cells.
13. An article comprising a shipping chamber having a chamber top and a chamber bottom, the chamber bottom having a surface having thereon a gel support, wherein the gel support comprises a minimal media, said article further comprising an organotypically cultured 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, wherein the chamber bottom lacks any liquid at the time of manufacture.