Laminated tissue grafts composed of Wharton's jelly and methods of making and using the same

Patent metadata

Field	Value
Publication number	US-10350049-B2
Application number	US-201213984843-A
Country	US
Kind code	B2
Filing date	Feb 13, 2012
Priority date	Feb 14, 2011
Publication date	Jul 16, 2019
Grant date	Jul 16, 2019

Abstract

Described herein are tissue grafts derived from the placenta with improved physical and biological properties. In one aspect, the tissue graft includes a first membrane comprising Wharton's jelly laminated with amnion, chorion, or a combination thereof. The presence of Wharton's jelly in the grafts enhances the performance of allograft amniotic-derived, caderivic allograft, xenograft, or alloplast soft tissue substitutes.

First claim

The invention claimed is:

1. A tissue graft comprising a first layer, a second layer, and a third layer laminated together, said first layer comprising a placental amnion, said second layer comprising a chorion, and said third layer comprising Wharton's jelly,
wherein the amnion comprises an exposed basement membrane and an amnion stromal layer, wherein the amnion stromal layer is adjacent to the chorion, and wherein the chorion comprises a chorion stromal layer, wherein the chorion stromal layer is adjacent to the Wharton's jelly,
wherein an intermediate layer of said amnion has not been substantially removed.

2. The graft of claim 1 , wherein the graft is substantially dry prior to use.

3. The graft of claim 2 which has been hydrated.

4. The graft of claim 1 , wherein the graft is hydrated with an aqueous solution comprising naturally occurring growth factors sourced from platelet concentrates, either using autologous blood collection and separation products, or xenograft sources that comprise fetal swine teeth and blood concentrates, purified natural bioactive agents, recombinant biological modifiers that comprise recombinant platelet derived growth factor and recombinant fibroblast growth factor, or any combination thereof.

5. The graft of claim 1 , wherein the graft is about 1 mm in thickness.

6. The graft of claim 1 , wherein the graft comprises laminin and laminin-5.

7. The graft of claim 1 , wherein the graft is soaked in platelet concentrates prior to use, said platelet concentrates sourced from expired banked blood.

8. The graft of claim 1 , wherein the graft is soaked with a bioactive agent comprising naturally occurring growth factors sourced from platelet concentrates, using autologous blood collection and separation products; bioactive agents sourced from allograft placentas; bone marrow aspirate; a solution of purified natural bioactive agents, recombinant bioactive agents, or any combination thereof.

9. The graft of claim 1 , wherein the amnion and chorion are obtained from a mammal other than a human.

10. A method for facilitating vascularization of a wound and promoting wound healing, the method comprising contacting the wound site with the graft of claim 1 .

11. A method for facilitating cell migration of gingival epithelia cells and promoting attachment of gingival epithelia cells to a tooth root, the method comprising contacting the gingival epithelia cells with the graft of claim 1 .

12. A method for promoting wound healing associated with a dental surgical procedure, comprising contacting the wound with the graft of claim 1 .

13. A method for preventing or reducing scar formation on or near the spine after a surgical procedure, the method comprising applying to a subject the tissue graft of claim 1 directly to the spinal dura of the subject or a region near the spine.

14. A method for treating a dural tear in a subject, the method comprising applying directly to the dural tear the tissue graft of claim 1 .

15. A method for promoting wound healing associated with an orthopedic application, associated with an ENT application, involving a subject's extremities, associated with an ophthalmological application, associated with a gynecological application, associated with an urological application, or associated with general surgery, wherein the method comprises contacting the wound with the graft of claim 1 .

16. A method for promoting wound healing in the human mucosa in the oral cavity, nose, throat, vagina, or rectum, the method comprising contacting the wound site with the graft of claim 1 .

17. A method for promoting the healing of a wound in a subject, the method comprising applying to the wound the graft of claim 1 , wherein the wound is in the cranial dura, a wound resulting from a perioplastic procedure, a frenum pull, in a patella, in a Schneiderian membrane in the sinus cavity, or is in soft tissue around a dental implant.

18. A method for preventing or reducing scar formation on or near a wound, the method comprising applying to the wound the graft of claim 1 .

Assignees

• Morse Brenda S
• Sith Somaly
• Spencer Randall
• Daniel John
• Tofe Robert
• Mimedx Group Inc

Inventors

• Morse Brenda S
• Sith Somaly
• Spencer Randall
• Daniel John
• Tofe Robert

Classifications

• A61P27/16

  Otologicals · CPC title

• A61P27/02

  Ophthalmic agents · CPC title

• A61P19/08

  for bone diseases, e.g. rachitism, Paget's disease · CPC title

• A61P19/02

  for joint disorders, e.g. arthritis, arthrosis · CPC title

• A61P11/02

  Nasal agents, e.g. decongestants · CPC title