Compositions and methods for treating the vertebral column
The present invention relates to compositions and methods useful for treating structures of the vertebral column, including vertebral bodies. In one embodiment, a method for promoting bone formation in a vertebral body comprising providing a composition comprising a PDGF solution and a biocompatible matrix and applying the composition to at least one vertebral body. Promoting bone formation in a vertebral body, according to some embodiments, can increase bone volume, mass, and/or density leading to an increase in mechanical strength of the vertebral body treated with a composition of the present invention.
1. A method for promoting or accelerating bone formation in at least one vertebral body of a patient comprising:
applying to the vertebral body a composition comprising:
a biocompatible matrix having incorporated therein a solution of platelet derived growth factor (PDGF) at a concentration in a range of about 0.1 mg/ml to about 1.0 mg/ml in a buffer, wherein the biocompatible matrix comprises (i) particles of a porous calcium phosphate in a range of about 100 μm to about 3 mm in size or (ii) (a) particles of a porous calcium phosphate in a range of about 100 μm to about 3 mm in size and (b) collagen,
wherein the calcium phosphate comprises interconnected pores and a porosity greater than 50%.
2. The method of claim 1 , wherein the biocompatible matrix comprises the particles of porous calcium phosphate and collagen.
3. The method of claim 2 , wherein the collagen comprises Type I collagen.
4. The method of claim 2 , wherein the weight ratio of calcium phosphate:collagen is about 80:20.
5. The method of claim 1 , wherein the PDGF is at a concentration of about 0.3 mg/ml.
6. The method of claim 1 , wherein the PDGF comprises PDGF-BB.
7. The method of claim 6 , wherein the PDGF comprises recombinant human PDGF-BB (rhPDGF-BB) or a fragment thereof.
8. The method of claim 7 , wherein the rhPDGF-BB comprises at least 65% of intact rhPDGF-BB.
9. The method of claim 7 , wherein the fragment of rhPDGF-BB is selected from the group consisting of amino acid sequences 1-31, 1-32, 33-108, 33-109 and 1-108 of the entire B chain.
10. The method of claim 1 , wherein the calcium phosphate comprises particles in a range of about 100 μm to about 300 μm in size.
11. The method of claim 1 , wherein the calcium phosphate comprises particles in a range of about 1000 μm to about 2000 μm in size.
12. The method of claim 1 , wherein the calcium phosphate comprises particles in a range of about 250 μm to about 1000 μm in size.
13. The method of claim 1 , where the calcium phosphate comprises β-tricalcium phosphate.
14. The method of claim 2 , wherein the composition is flowable.
15. The method of claim 14 , wherein applying the composition to the vertebral body comprises injecting the composition into the vertebral body.
16. The method of claim 1 , wherein the method prevents or inhibits vertebral compression fractures.
17. The method of claim 1 , further comprising locally or systemically administering to the patient at least one additional pharmaceutical composition.
18. The method of claim 17 , wherein the at least one additional pharmaceutical composition comprises a vitamin or an osteoclast inhibitor.
19. The method of claim 17 , wherein the locally administering comprises disposing the at least one additional pharmaceutical composition in or around the at least one vertebral body.
20. The method of claim 19 , wherein the patient has undergone kyphoplasty or vertebroplasty.
21. The method of claim 17 , wherein the systemically administering comprises orally administering, intravenously administering, or a combination thereof.