Cross-linked dehydrated placental tissue grafts and methods for making and using the same

Patent metadata

Field	Value
Publication number	US-12083244-B2
Application number	US-201615267026-A
Country	US
Kind code	B2
Filing date	Sep 15, 2016
Priority date	Dec 22, 2011
Publication date	Sep 10, 2024
Grant date	Sep 10, 2024

Abstract

Described herein are tissue grafts produced by contacting dehydrated placental tissue grafts with a cross-linking agent. The tissue grafts described herein provide barrier and prevent the migration of a bioactive agent from the wound. Thus, the tissue grafts enhance wound healing while preventing the undesirable migration of a bioactive agent from the wound. Methods for making and using the cross-linked grafts are also described herein.

First claim

What is claimed is:

1. A method for producing a dehydrated, cross-linked placental tissue graft, the method consisting of
i) contacting a dehydrated placental tissue graft with a solution comprising a cross-linking agent, thereby forming a cross-linked placental tissue graft; and
ii) dehydrating the cross-linked placental tissue graft formed in step 1), thereby forming the dehydrated, cross-linked placental tissue graft;
wherein the dehydrated placental tissue graft comprises at least two layers of amnion, or at least one layer of each of chorion and amnion; and

wherein at least one amnion layer comprises an amniotic fibroblast cell layer.

2. A method for enhancing wound healing in a subject comprising applying a tissue graft produced according to the method of claim 1 to the wound.

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

4. The method of claim 3 , wherein the surgical procedure comprises a posterior procedure.

5. The method of claim 4 , wherein the posterior procedure is a laminectomy or discectomy.

6. The method of claim 3 , wherein the surgical procedure comprises an anterior procedure.

7. The method of claim 6 , wherein the anterior procedure is an Anterior Lumbar Interbody Fusion (ALIF) or Transforaminal Lumbar Interbody Fusion (TLIF).

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

9. The method of claim 2 , wherein the tissue graft comprises one or more additional placental components.

10. The method of claim 9 , wherein the one or more additional placental components comprise amnion, amnion membrane, chorion, Wharton's jelly, or any combination thereof.

11. The method of claim 2 , wherein the placental tissue graft comprises a laminate of amnion and chorion.

12. The method of claim 2 , wherein the placental tissue graft comprises a plurality of chorion and/or amnion membranes laminated to one another.

13. The method of claim 2 , wherein the dehydrated placental tissue graft was chemically dehydrated or thermally dehydrated.

14. The method of claim 2 , wherein the cross-linking agent comprises a sugar, a dialdehyde, an epoxide, a hydrazide, or a carbodiimide.

15. The method of claim 14 , wherein the sugar comprises D-ribose, glycerose, altrose, talose, ertheose, glucose, lyxose, mannose, xylose, gulose, arabinose, idose, allose, galactose, maltose, lactose, sucrose, cellibiose, gentibiose, melibiose, turanose, trehalose, isomaltose, or any combination thereof.

16. The method of claim 3 , wherein the tissue graft comprises one or more additional placental components.

17. The method of claim 16 , wherein the one or more additional placental components comprise amnion, amnion membrane, chorion, Wharton's jelly, or any combination thereof.

18. The method of claim 3 , wherein the placental tissue graft comprises a laminate of amnion and chorion.

19. The method of claim 3 , wherein the placental tissue graft comprises a plurality of chorion and/or amnion membranes laminated to one another.

20. The method of claim 3 , wherein the cross-linking agent comprises a sugar, a dialdehyde, an epoxide, a hydrazide, or a carbodiimide.

21. The method of claim 20 , wherein the sugar comprises D-ribose, glycerose, altrose, talose, ertheose, glucose, lyxose, mannose, xylose, gulose, arabinose, idose, allose, galactose, maltose, lactose, sucrose, cellibiose, gentibiose, melibiose, turanose, trehalose, isomaltose, or any combination thereof.

22. The method of claim 1 , wherein the placental tissue graft comprises at least one layer of each of chorion and amnion.

23. The method of claim 1 , wherein the dehydrated, cross-linked placental tissue graft is opaque.

Assignees

• Mimedx Group Inc

Inventors

• Koob Tom
• Daniel John
• Spencer Randall

Classifications

• A61L27/54

  Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} · CPC title

• A61K35/50

  Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells · CPC title

• A61L15/40

  containing ingredients of undetermined constitution or reaction products thereof {, e.g. plant or animal extracts} · CPC title

• A61L27/60

  Materials for use in artificial skin · CPC title

• A61L27/3687

  characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents · CPC title