Non-cultured, partially digested, cryopreserved cartilage product

Patent metadata

Field	Value
Publication number	US-12268797-B2
Application number	US-202217681064-A
Country	US
Kind code	B2
Filing date	Feb 25, 2022
Priority date	Jul 11, 2012
Publication date	Apr 8, 2025
Grant date	Apr 8, 2025

Abstract

This invention provides porated cartilage products and methods of producing porated cartilage products. Optionally, the cartilage products are sized, porated, and digested to provide a flexible cartilage product. Optionally, the cartilage products comprise viable chondrocytes, bioactive factors such as chondrogenic factors, and a collagen type II matrix. Optionally, the cartilage products are non-immunogenic.

First claim

What is claimed is:

1. A flexible cryopreserved partially digested cartilage material comprising non-cultured cartilage isolated from a subject, wherein:
the material comprises an extracellular matrix, growth factors, and chondrocytes,
wherein the extracellular matrix, growth factors, and chondrocytes were embedded in the material when it was isolated from the subject, and
wherein at least 70% of the chondrocytes are viable; and

the material has a first circular-shaped surface, an opposing second circular-shaped surface, and a thickness of 0.2 millimeters (mm) to 2 mm,
wherein the first circular-shaped surface has an array of cavities capable of facilitating migration of the chondrocytes,

wherein, after cryopreserving, the material retains the structural and functional properties of natural cartilage,
wherein digestion of the material is limited to an amount that preserves the viability of the chondrocytes and/or the structural and functional properties of natural cartilage, and
wherein digestion is performed in a manner that retains interaction between the extracellular matrix and the chondrocytes.

2. The flexible cryopreserved cartilage material of claim 1 , wherein the growth factors comprise basic fibroblast growth factor (bFGF) and transforming growth factor beta 1 (TGF-β1).

3. The flexible cryopreserved cartilage material of claim 2 , wherein the growth factors further comprise bone morphogenic protein 2 (BMP-2).

4. The flexible cryopreserved cartilage material of claim 3 , wherein the growth factors further comprise insulin-like growth factor 1 (IGF-1) and bone morphogenic protein 7 (BMP-7).

5. The flexible cryopreserved cartilage material of claim 1 , wherein the extracellular matrix comprises collagen fibrils that include type II collagen.

6. The flexible cryopreserved cartilage material of claim 1 , wherein the cartilage is hyaline cartilage.

7. The flexible cryopreserved cartilage material of claim 1 , wherein the array of cavities is arranged in a grid pattern.

8. The flexible cryopreserved cartilage material of claim 1 , wherein the second circular-shaped surface does not have an array of cavities capable of facilitating migration of the viable chondrocytes.

9. The flexible cryopreserved cartilage material of claim 1 , wherein the material is flexible such that it capable of being, rolled, folded, or bent without breaking.

10. The flexible cryopreserved cartilage material of claim 1 , wherein the cartilage material comprises a radial layer, a transitional layer, and a tangential layer.

11. The flexible cryopreserved cartilage material of claim 1 , wherein the material is disk-shaped.

12. The flexible cryopreserved cartilage material of claim 11 , wherein the material has a diameter of 10 millimeters (mm) to 20 millimeters (mm).

13. The flexible cryopreserved cartilage material of claim 11 , wherein the material has a diameter of 20 millimeters (mm).

14. The flexible cryopreserved cartilage material of claim 1 , wherein the material is comprised within a cryopreservation medium.

15. The flexible cryopreserved cartilage material of claim 1 , wherein at least 80% of the chondrocytes are viable.

16. The flexible cryopreserved cartilage material of claim 1 , wherein the flexible cryopreserved cartilage material is stored at a temperature of 0° C. to 10° C.

17. The flexible cryopreserved cartilage material of claim 1 , wherein the flexible cryopreserved cartilage material is stored at a temperature of −75° C. to −85° C.

18. A method of administering a flexible cryopreserved cartilage material of claim 1 to a person, the method comprising administering the cartilage material to the person.

19. The method of claim 18 , wherein the cartilage material is thawed prior to administering the cartilage material to the person.

20. The method of claim 19 , wherein the thawed cartilage material has a temperature of about 37° C.

21. The method of claim 18 , wherein the cartilage material is administered arthroscopically to the person.

22. The method of claim 18 , wherein injured cartilage is removed from the person and replaced with the cartilage material.

23. The method of claim 22 , wherein the injured cartilage is articular cartilage.

24. The method of claim 22 , wherein the removed injured cartilage is disc-shaped, and wherein the cartilage material is disc-shaped.

25. The method of claim 18 , wherein the cartilage material promotes chondrogenesis in the person.

26. The method of claim 18 , wherein the array of cavities on the first circular-shaped surface is arranged in a grid pattern.

Assignees

• Osiris Therapeutics Inc

Inventors

• Yoo Dana Sue
• Kuang Jin-Qiang
• Paden Jaime
• Maxson Scott A
• Danilkovitch Alla
• Lopez Erasmo
• Tom Samson

Classifications

• A61L2300/64

  Animal cells · CPC title

• A61L27/3683

  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 title

• A61L27/3608

  Bone, e.g. demineralised bone matrix [DBM], bone powder · CPC title

• A61L27/50

  Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} · CPC title

• A61L27/56

  Porous materials, {e.g. foams or sponges} · CPC title