Method and Composition for Hypothermic Storage of Placental Tissue
A tissue storage solution includes hypothermic storage compositions and methods. The hypothermic storage composition includes media containing Dulbecco's modified Eagle's medium (DMEM) and albumin. A method of hypothermically storing tissue includes storing such tissue in a storage medium including DMEM and albumin. A method for wound or defect treatment includes applying tissue, stored in a hypothermic storage medium containing DMEM and albumin, to the site of such wound or defect.
1 . A method for treating a wound comprising:
hypothermically storing a placental membrane in a container including a solution including Dulbecco's modified Eagle's medium (DMEM) and human plasma albumin, wherein the human plasma albumin promotes cell viability and membrane integrity of the placental membrane,
removing the placental membrane from the container, and
applying the placental membrane to a wound.
2 . The method according to claim 1 comprising applying a stromal-side of the placental membrane to the wound.
3 . The method according to claim 1 comprising processing the placental membrane into placental membrane pieces prior to storing the placental membrane in the container.
4 . The method according to claim 3 wherein the placental membrane pieces have particle sizes ranging from 0.1 mm to 5 mm.
5 . The method according to claim 1 comprising applying the placental membrane to the wound in combination with amniotic fluid cells.
6 . The method according to claim 1 comprising applying the placental membrane to the wound in combination with cartilage pieces.
7 . The method according to claim 6 comprising applying the cartilage pieces and the placental membrane to the wound in a 3:1 to 1:3 ratio by volume.
8 . The method according to claim 1 comprising storing the placental membrane in the solution for at least 14 days before applying the placental membrane to the wound.
9 . The method according to claim 1 wherein the placental membrane exhibits a ratio of live cells to dead cells greater than 2.0 following three hundred sixty hours of being hypothermically stored in the solution.
10 . The method according to claim 1 wherein the placental membrane exhibits a ratio of live cells to dead cells of greater than about 1.5 following seven hundred twenty hours of being hypothermically stored in the solution.
11 . The method according to claim 1 wherein the placental membrane exhibits a cell viability in a range between about 45% and 85% following one thousand hours of being hypothermically stored in the solution.
12 . The method according to claim 1 comprising morselizing the placental membrane and adsorbing the morselized placental membrane to a mammalian collagen matrix prior to hypothermically storing the placental membrane in the solution.
13 . The method according to claim 1 comprising meshing the placental membrane prior to hypothermically storing the placental membrane in the container.
14 . The method according to claim 1 comprising stretching the meshed placental membrane prior to applying the meshed membrane to the wound.
15 . The method according to claim 1 wherein the wound is a burn.
16 . The method according to claim 1 wherein the wound is a laceration.
17 . The method according to claim 1 wherein the placental membrane includes no placental membrane-derived cultured cells.
18 . A method of treating a wound comprising storing a placental membrane for a period of at least fourteen days, and thereafter, applying the placental membrane to a wound wherein the placental membrane exhibits a ratio of live cells to dead cells of at least 1:1 when applied to the wound.
19 . The method according to claim 18 comprising periodically testing the placental membrane for contamination during the period and applying the placental membrane to the wound only if no contamination exists.
20 . The method according to claim 18 wherein the placental membrane exhibits a ratio of live cells to dead cells greater than 2.0 following three hundred sixty hours of being stored.
21 . The method according to claim 18 wherein the placental membrane exhibits a ratio of live cells to dead cells greater than about 1.5 following seven hundred twenty hours of being stored.
22 . The method according to claim 18 wherein the placental membrane exhibits a ratio of live cells to dead cells of 1.0 or more following one thousand hours of being stored.
23 . The method according to claim 18 wherein the placental membrane has a total protein content of more than about 300 ng of protein per mg of the placental membrane following one thousand hours of being stored.
24 . The method according to claim 18 wherein the placental membrane has a tissue inhibiting matrix metalloproteinases 1 , 2 and 4 protein content of more than 250 ng of protein per mg of the placental membrane following one thousand hours of being stored.
25 . The method according to claim 18 wherein the placental membrane is hypothermically stored in containers including Dulbecco's modified Eagle's medium (DMEM) and human plasma albumin.
26 . The method according to claim 18 wherein the placental membrane is hypothermically stored in containers including a buffered solution including Dulbecco's modified Eagle's medium (DMEM) and at least about 0.025% w/v recombinant human plasma albumin.
27 . The method according to claim 18 wherein the placental membrane is hypothermically stored in containers including between 20 mM and 30 mM HEPES buffer, Dulbecco's modified Eagle's medium (DMEM) and between 2.0 g/L and 3.0 g/L human plasma albumin.
28 . The method according to claim 18 wherein the placental membrane is not frozen or dehydrated prior to being applied to the wound.
29 . A method a treating a wound comprising:
storing amniotic tissue in a container for at least fourteen days, the container including Dulbecco's modified Eagle's medium (DMEM) and human plasma albumin, and thereafter,
applying the amniotic tissue to the wound,
wherein the amniotic tissue includes more live cells than dead cells when applied to the wound.