IP Library Granted Patent US 12,150,445
Granted Patent B2
US 12,150,445 · App. 17/974,395 · Granted Nov 26, 2024

Method and composition for hypothermic storage of placental tissue

Inventors: Howard P. Walthall, Jr. (Birmingham, AL); Katie C. Mowry (Gardendale, AL); Jeremy B. Vines (Birmingham, AL)
Assignee: PRIME MERGER SUB, LLC
A01N1/0226A01N1/0242A01N1/0263A61K35/50C12N5/0605
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Quick Facts
Patent No.
US 12,150,445
App. No.
17/974,395
Granted
Nov 26, 2024
Kind
B2
Abstract

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.

Claims (21)

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,

storing the placental membrane in the solution for at least 14 days before applying the placental membrane to a wound,

removing the placental membrane from the container, and

applying the placental membrane to the 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 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.

9. 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.

10. 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.

11. 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.

12. The method according to claim 1 comprising meshing the placental membrane prior to hypothermically storing the placental membrane in the container.

13. The method according to claim 1 comprising stretching the meshed placental membrane prior to applying the meshed membrane to the wound.

14. The method according to claim 1 wherein the wound is a burn.

15. The method according to claim 1 wherein the wound is a laceration.

16. The method according to claim 1 wherein the placental membrane includes no placental membrane-derived cultured cells.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 11, 2024
From: WALTHALL, HOWARD P., JR.; MOWRY, KATIE C.; VINES, JEREMY B.
To: NUTECH MEDICAL, INC.
Reel/Frame 068554/0726 →
MERGER AND CHANGE OF NAME Recorded Sep 11, 2024
From: NUTECH MEDICAL, INC.; PRIME MERGER SUB, LLC
To: PRIME MERGER SUB, LLC
Reel/Frame 068554/0832 →
Continuity (3)
Continuation 14972535 · Dec 17, 2015
Division 14508398 · Oct 7, 2014
Related Publication 20230077597A1 · Mar 16, 2023