Claims for Patent: 8,221,500

Summary for Patent: 8,221,500

Title:	Cartilage allograft plug
Abstract:	The invention is directed toward a cartilage repair assembly comprising a shaped allograft structure of subchondral bone with an integral overlying cartilage cap which is treated to remove cellular debris and proteoglycans and milled allograft cartilage in a bioabsorbable carrier. The shaped structure is dimensioned to fit in a drilled bore in a cartilage defect area so that either the shaped bone or the cartilage cap engage the side wall of the drilled bore in an interference fit and is in contact with a milled cartilage and biocompatible carrier mixture allowing cell transfer throughout the defect area. A method for inserting the shaped allograft structure into a cartilage defect area is also disclosed.
Inventor(s):	Truncale; Katherine Gomes (Hillsborough, NJ), Gertzman; Arthur A. (Flemington, NJ), Sunwoo; Moon Hae (Old Tappan, NJ), Tomford; William W (Belmont, MA)
Assignee:	Musculoskeletal Transplant Foundation (Edison, NJ)
Application Number:	12/179,034
Patent Claims:	1. A method for repairing a defect in articular cartilage of a human patient, said method comprising the steps of: (a) providing milled allograft cartilage pieces; (b) combining the milled allograft cartilage pieces with a biocompatible carrier to form a cartilage mixture; (c) providing a non-decellularized osteochondral plug harvested from a human donor; (d) treating the non-decellularized osteochondral plug to remove cellular material, chondrocytes, pluripotent mesenchymal cells and proteoglycans therefrom; (e) lyophilizing the decellularized osteochondral plug to form a lyophilized decellularized osteochondral plug having a subchondral bone base and a cartilage cap attached to a first end of the subchondral bone base, (f) providing a plurality of passageways in the lyophilized, decellularized osteochondral plug, the passageways extending from the first end to a second end of the subchondral bone base; (g) implanting the cartilage mixture into a bore formed at the patient's articular cartilage defect; and (h) implanting the lyophilized, decellularized osteochondral plug into the bore so as to be in juxtaposition to the cartilage mixture, such that at least a portion of the cartilage mixture is received in the passageways to thereby promote chondrocyte migration into and proliferation within the cartilage cap, while enhancing tissue integration between the lyophilized, decellularized allograft osteochondral plug and patient tissue adjacent the bore. 2. The method of claim 1, wherein the lyophilized, decellularized osteochondral plug is cylindrically shaped. 3. The method of claim 1, wherein the passageways include throughgoing bores and said providing step (f) includes drilling the throughgoing bores in the subchondral bone base. 4. The method of claim 1, wherein the passageways include longitudinal grooves and said providing step (f) includes forming the longitudinal grooves on an outer surface of the lyophilized, decellularized osteochondral plug. 5. The method of claim 4, wherein said step (f) includes forming the longitudinal grooves on an outer surface of the subchondral bone base. 6. The method of claim 1, wherein the lyophilized, decellularized osteochondral plug has a diameter within a range of from 1 mm to 30 mm. 7. The method of claim 1, wherein the lyophilized, decellularized osteochondral plug has a diameter within a range of from about 3 mm to about 10 mm. 8. The method of claim 1, wherein the milled allograft cartilage pieces each have at least one dimension of less than 1 mm. 9. The method of claim 1, wherein the milled allograft cartilage pieces are hyaline cartilage. 10. The method of claim 1, wherein the cartilage mixture includes a chondrogenic stimulating factor. 11. The method of claim 10, wherein the chondrogenic stimulating factor is one or more of a group consisting of growth factors (FGF-2, FGF-5, IGF-1, TGF-.beta., BMP-2, BMP-7, PDGF, VEGF), human allogenic or autologous chondrocytes, human allogenic or autologous bone marrow cells, stem cells, demineralized bone matrix, insulin, insulin-like growth factor-1, transforming growth factor-B, interleukin-1 receptor antagonist, hepatocyte growth factor, platelet-derived growth factor, Indian hedgehog and parathyroid hormone-related peptide and bioactive glue. 12. The method of claim 1, wherein the biocompatible carrier comprises one or more of a group consisting of sodium hyaluronate, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran and polymers. 13. The method of claim 1, wherein the cartilage mixture includes milled allograft cartilage pieces which have been lyophilized so that their water content is within a range of from about 0.1% to about 8.0%. 14. The method of claim 1, wherein the milled allograft cartilage pieces constitute a weight percentage of the cartilage mixture within a range of from about 25% to about 50%. 15. The method of claim 1, wherein the milled allograft cartilage pieces constitute a weight percentage of the cartilage mixture within a range of from about 15% to about 30%. 16. The method of claim 1, wherein the lyophilized, decellularized osteochondral plug has a water content in the range of from about 0.1% to about 8.0%. 17. The method of claim 1, wherein the cartilage mixture includes an additive consisting of one or more of a group consisting of human allogenic cartilage cells, and human bone marrow cells. 18. The method of claim 1, wherein the bore is cylindrical and transverse to the cartilage surface surrounding the bore. 19. The method of claim 1, wherein the bore is cylindrical and angled with respect to the cartilage surface surrounding the bore. 20. The method of claim 1, wherein said step (h) is performed to create an interference fit between the lyophilized, decellularized osteochondral plug and an inner surface of the bore. 21. The method of claim 1, wherein said step (h) is performed such that the cartilage cap of the lyophilized, decellularized osteochondral plug is substantially flush with the surface of the patient's adjacent cartilage. 22. The method of claim 1, wherein said step (g) is performed prior to said step (h).

Details for Patent 8,221,500

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2023-05-16