Nerve grafts containing regenerative compounds, methods of making the same, and methods of treatment using the same

Patent metadata

Field	Value
Publication number	US-2023191002-A1
Application number	US-202218068715-A
Country	US
Kind code	A1
Filing date	Dec 20, 2022
Priority date	Dec 22, 2021
Publication date	Jun 22, 2023
Grant date	—

Abstract

A method of preparing a nerve graft includes submerging a nerve graft in a solution including FK506 and a solvent to promote incorporation of FK506 into the nerve graft. A tissue graft includes nerve tissue and FK506 incorporated within the nerve tissue. In the tissue graft, the FK506 is free of hydrogel and not encapsulated.

First claim

What is claimed is:

1 . A method of preparing a nerve graft, the method comprising:
submerging a nerve graft in a solution comprising FK506 and a solvent to promote incorporation of FK506 into the nerve graft.

2 . The method of claim 1 , wherein the solvent comprises dimethyl sulfoxide (DMSO).

3 . The method of claim 2 , wherein the solution comprises between about 1% and about 15% by volume DMSO.

4 . The method of claim 1 , wherein the solution comprises between about 1 μg/mL to about 50 mg/mL FK506.

5 . The method of claim 1 , wherein the solution comprises one or more soluble salts of: sodium, potassium, calcium, magnesium, or other monovalent or divalent metal cationic salts.

6 . The method of claim 1 , further including sterilizing the nerve graft by exposing the nerve graft to gamma irradiation.

7 . The method of claim 6 , wherein sterilizing the nerve graft is performed while the nerve graft is in the solution.

8 . The method of claim 1 , wherein the nerve graft is in the solution for a period of at least one day.

9 . The method of claim 1 , wherein the nerve graft is in the solution for a period of at least one week.

10 . The method of claim 1 , wherein the nerve graft comprises acellular nerve tissue.

11 . A method of preparing a nerve graft, the method comprising:
exposing a nerve graft to a solution comprising FK506 such that the FK506 is at least partially incorporated within one or more portions of the nerve graft; sterilizing the nerve graft; and storing the nerve graft.

12 . The method of claim 11 , wherein storing the nerve graft is performed at room temperature for a period of at least one day.

13 . The method of claim 11 , wherein the nerve graft has a diameter of between about 0.5 mm and about 8 mm.

14 . The method of claim 11 , wherein the nerve graft and the solution are contained within packaging.

15 . The method of claim 14 , wherein the nerve graft and the solution are exposed to gamma irradiation while being contained within the packaging.

16 . The method of claim 11 , wherein the nerve graft is placed in the solution for a period of time sufficient for a concentration of FK506 within the nerve graft to reach a steady-state.

17 . A tissue graft, comprising:
nerve tissue; and FK506 incorporated within the nerve tissue, the FK506 being free of hydrogel and not encapsulated.

18 . The tissue graft of claim 17 , wherein the tissue graft comprises acellular nerve tissue.

19 . The tissue graft of claim 17 , wherein FK506 is distributed approximately uniformly within the tissue graft.

20 . The tissue graft of claim 17 , wherein FK506 is distributed within the tissue graft so as to form one or more areas having a relatively higher concentration of FK506.

21 . The tissue graft of claim 20 , wherein the tissue graft has a relatively higher concentration of FK506 in a hydrophobic portion of the nerve tissue.

22 . The tissue graft of claim 17 , wherein the nerve tissue is at least partially submerged within a solution comprising FK506 and DMSO.

Assignees

• Axogen Corp

Inventors

• Tajdaran Kasra
• Scopelianos Angelo

Classifications

• A61L27/22

  Polypeptides or derivatives thereof {, e.g. degradation products} · CPC title

• A61L27/02

  Inorganic materials · CPC title

• A61L27/3878 Primary

  Nerve tissue, brain, spinal cord, nerves, dura mater · CPC title

• A61L27/3604 Primary

  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

• A61L27/54

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