Placental tissue grafts and improved methods of preparing and using the same

Patent metadata

Field	Value
Publication number	US-11752174-B2
Application number	US-202017120626-A
Country	US
Kind code	B2
Filing date	Dec 14, 2020
Priority date	Sep 7, 2007
Publication date	Sep 12, 2023
Grant date	Sep 12, 2023

Abstract

Described herein are tissue grafts derived from the placenta. The grafts are composed of at least one layer of amnion tissue where the epithelium layer has been substantially removed in order to expose the basement layer to host cells. By removing the epithelium layer, cells from the host can more readily interact with the cell-adhesion bio-active factors located onto top and within of the basement membrane. Also described herein are methods for making and using the tissue grafts. The laminin structure of amnion tissue is nearly identical to that of native human tissue such as, for example, oral mucosa tissue. This includes high level of laminin-5, a cell adhesion bio-active factor show to bind gingival epithelia-cells, found throughout upper portions of the basement membrane.

First claim

What is claimed is:

1. A tissue graft comprising a first membrane comprising an amnion and at least one additional membrane laminated to the first membrane, wherein the amnion comprises a basement membrane, a compact layer, and a fibroblast layer, and the at least one additional membrane is adjacent to the fibroblast layer;
wherein each additional membrane consists of amnion, chorion, allograft pericardium, allograft acellular dermis, amniotic membrane, Wharton's jelly, purified xenograft Type-1 collagen, biocellulose polymers or copolymers, biocompatible synthetic polymer or copolymer films, purified small intestinal submucosa, bladder acellular matrix, cadaveric fascia, or any combination thereof; and
wherein said graft comprises a plurality of holes.

2. The graft of claim 1 , wherein the at least one additional membrane comprises amnion, chorion, or a combination thereof.

3. The graft of claim 1 , wherein said at least one additional membrane comprises at least two amnion membranes.

4. The graft of claim 1 , wherein said at least one additional membrane comprises four amnion membranes.

5. The graft of claim 1 , wherein the at least one additional membrane comprises chorion.

6. The graft of claim 1 , wherein the tissue graft further comprises a second membrane comprising an exposed basement membrane and stromal layer, wherein the stromal layer of the second membrane is laminated to the at least one additional membrane.

7. The graft of claim 1 , wherein at least one of the membranes comprises a naturally occurring growth factor, a platelet concentrate, a bone marrow aspirate, stem cells, or an antibiotic.

8. The graft of claim 1 , wherein the number of membranes laminated to the first membrane is from 1 to 10.

9. The graft of claim 1 , wherein the graft has a thickness from 0.2 mm to 10 mm.

10. The graft of claim 1 , wherein the holes have a diameter from 0.2-2.0 mm.

11. The graft of claim 1 , wherein the holes have a diameter from 0.2-0.5 mm.

12. The graft of claim 1 , wherein the holes are spaced from 1 mm to 5 mm apart.

13. The graft of claim 1 , wherein the holes are spaced from 2 mm to 4 mm apart.

14. A method for treating a wound present on mucosal tissue of a subject comprising applying the tissue graft of claim 1 to the wound.

15. The method of claim 14 , wherein the mucosal tissue is present in the oral cavity, nose, throat, vagina, or rectum of the subject.

16. A method for treating a dental defect in a subject comprising applying the tissue graft of claim 1 to the defect.

17. The method of claim 16 , wherein the dental defect comprises a gingival recession, a root carie, or an exposed root.

18. The method of claim 16 , wherein the graft is applied to directly to the surface of a tooth root.

Assignees

• Mimedx Group Inc

Inventors

• Daniel John
• Spencer Randall
• Russo John
• Tofe Robert

Classifications

• A61L27/3683 Primary

  subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment · CPC title

• A61K35/28 Primary

  Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells · CPC title

• A61L27/3834

  Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells · CPC title

• A61L2430/40

  Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking · CPC title

• A61L27/3604

  characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel · CPC title