Compositions and methods for forming and strengthening bone

• US 9,254,301 B2
• Filed: 10/22/2013
• Issued: 02/09/2016
• Est. Priority Date: 03/30/1998
• Status: Expired due to Fees

• Current Assignee: Marfly 2, LP
• Original Assignee: Marfly2 LP
• Inventors: Marchosky, Jose Alexander
• Primary Examiner(s): Fubara, Blessing M
• Application Number:
  US14/060,129
• Publication Number:
  US 20140186459A1
• Time in Patent Office: 840 Days
• Field of Search: 424/549
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/722 Chitin, chitosan
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 31/734 Alginic acid
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61K 38/1866 Vascular endothelial growth factor [VEGF]
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

Compositions are provided which stimulate bone growth. Also provided are methods for utilizing the compositions for filling in bone defects, promoting rapid fusion of bone fractures, grafts, and bone-prostheses, and promoting strengthening of osteoporotic bones.

Claims

1. A composition for promoting growth and strengthening of bone comprising a mixture of a chitosan or chitosan derivative, cancellous bone, and demineralized bone matrix;

wherein the chitosan derivative is imidazolyl chitosan or methylpyrrolidoninone chitosan.

2. A composition of claim 1, wherein the demineralized bone matrix is present at 10%;

the cancellous bone is present at 10%; and

the composition comprises a gel material constituted 3% (w/v) of the chitosan or the chitosan derivative.

3. A composition of claim 1, wherein the demineralized bone matrix is present at 20%;

the cancellous bone is present at 20%; and

the composition comprises a gel material constituted 3% (w/v) of the chitosan or the chitosan derivative.

4. A composition of claim 1, wherein the demineralized bone matrix is present at 10%;

the cancellous bone is present at 30%; and

the composition comprises a gel material constituted 3% (w/v) of the chitosan or the chitosan derivative.

5. A method of inducing bone formation in a vertebrate comprising applying a composition of claim 1 to a site in the vertebrate where bone formation is desired.

6. The method of claim 5, wherein the site is the junction of an allograft or autograft and a bone.

7. The method of claim 5, wherein the site is the junction of a bone and a bone prosthesis.

8. The method of claim 5, wherein the site is a fracture.

9. A composition for promoting growth and strengthening of bone comprising a mixture of alginate, calcium, cancellous bone, and demineralized bone matrix.

10. A composition of claim 9, wherein the demineralized bone matrix is present at 10%;

the cancellous bone is present at 30%; and

the composition comprises a gel material constituted 3% (w/v) of the alginate.

11. A composition of claim 9, wherein the demineralized bone matrix is present at 20%;

the cancellous bone is present at 20%; and

the composition comprises a gel material constituted 3% (w/v) of the alginate.

12. A composition of claim 9, wherein the demineralized bone matrix is present at 10%;

the cancellous bone is present at 10%; and

the composition comprises a gel material constituted 3% (w/v) of the alginate.

13. A composition, comprising:

(a) one or more angiogenesis-stimulating materials;

(b) an osteoinductive material;

(c) a scaffolding material comprising cancellous bone; and

(d) a gel material.

14. The composition of claim 13 wherein the gel material comprises alginate.

15. The composition of claim 14, also comprising calcium chloride or tricalcium phosphate.

16. The composition of claim 13 wherein the gel material comprises chitosan, imidazolyl chitosan or methylpyrrolidoninone chitosan.

17. The composition of claim 13, wherein the osteoinductive material comprises demineralized bone matrix.

18. The composition of claim 13, wherein the osteoinductive material comprises a bone morphogenic protein.