Placental tissue grafts

• US 8,357,403 B2
• Filed: 09/08/2008
• Issued: 01/22/2013
• Est. Priority Date: 09/07/2007
• Status: Active Grant

• Current Assignee: Mimedx Group Incorporated
• Original Assignee: Mimedx Group Incorporated
• Inventors: Daniel, John, Tofe, Robert, Spencer, Randall, Russo, John
• Primary Examiner(s): Ford, Allison
• Application Number:
  US12/206,508
• Publication Number:
  US 20120078378A1
• Time in Patent Office: 1,597 Days
• Field of Search: None
• US Class Current: 424/583
• CPC Class Codes: A61F 2210/00 Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2230/00 Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61K 35/19 Platelets; Megacaryocytes
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 35/33 Fibroblasts
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3604 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 Class Codes: A61L 27/3683 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 Class Codes: A61L 27/3834 Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 156/1039 Surface deformation only of sandwich or lamina [e.g., embossed panels]

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.

Claims

1. A method for preparing a tissue graft, comprising the steps:

(a) processing a placenta comprising an amnion membrane layer and a chorion tissue layer to separate the chorion tissue layer from the amnion layer, wherein the amnion membrane layer comprises a first side comprising epithelial cells adjacent to a basement membrane and a second side comprising a jelly-like fibroblast cellular layer;

(b) removing substantially all of the epithelial cells to expose the basement membrane of the amnion membrane layer while maintaining the jelly-like fibroblast cellular layer to produce a first membrane;

(c) laminating a second amnion membrane layer onto the first amnion membrane layer, wherein the epithelial cells have not been removed from the first side of the second amnion membrane, and wherein the fibroblast layer of the first amnion membrane layer is adjacent to the epithelial layer of the second amnion membrane layer; and

(d) optionally laminating one or more additional membranes on the first or second amnion membrane layers to produce a layered tissue graft.

2. The method of claim 1, further comprising, after step (a) but prior to step (b), soaking the amniotic membrane layer in an antibiotic solution.

3. The method of claim 1, further comprising the step of rinsing the amniotic membrane layer to remove the antibiotic solution.

4. The method of claim 1, further comprising, after step (a) but prior to step (b), physically cleaning the amniotic membrane to remove blood clots and other contaminates.

5. The method of claim 1, wherein step (b) comprises scraping the epithelium layer to substantially remove the epithelium cells.

6. The method of claim 1, wherein the one or more additional membranes comprises amnion, chorion, allograft pericardium, allograft acelluar 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 fasia, or any combination thereof.

7. The method of claim 1, wherein the one or more additional membranes comprises chorion, amnion, or a combination thereof.

8. The method of claim 1, wherein the placenta is cleaned prior to step (a).

9. The method of claim 1, further comprising:

(d) mounting the layered tissue graft onto a surface of a drying fixture; and

(e) dehydrating the layered tissue graft.

10. The method of claim 9, wherein the basement membrane of the first membrane is adjacent to the surface of the drying fixture.

11. The method of claim 1, wherein the first membrane and the one or more additional membrane are laminated by fibrin glue or gelatin.

12. The method of claim 1, wherein the first membrane and the one or more additional membrane are laminated by a photochemical technique or suturing.