Compositions and methods for treating the vertebral column
View Patent ↗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 increasing bone density in a vertebral body in an individual comprising:
applying a composition to the vertebral body,
wherein the composition consists of a biocompatible matrix having incorporated therein a solution consisting 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 consists of (i) particles of a porous calcium phosphate in a range of about 100 μm to about 5 mm in size or (ii) (a) particles of a porous calcium phosphate in a range of about 100 μm to about 5 mm in size and (b) collagen, and
wherein the calcium phosphate comprises interconnected pores.
2. The method of claim 1 , wherein the vertebral body is a high risk vertebral body.
3. The method of claim 1 , wherein the vertebral body is an osteoporotic vertebral body.
4. The method of claim 1 , wherein the individual is a medically compromised patient.
5. The method of claim 1 , wherein the method is for prevention or decreasing the likelihood of a vertebral compression fracture.
6. The method of claim 1 , wherein the PDGF is at a concentration of about 0.3 mg/ml.
7. The method of claim 1 , wherein the PDGF comprises PDGF-BB.
8. The method of claim 1 , wherein the PDGF comprises rhPDGF-BB or a fragment thereof, wherein the fragment 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.
9. The method of claim 8 , wherein the rhPDGF-BB comprises at least 65% of intact rhPDGF-BB.
10. The method of claim 1 , wherein the calcium phosphate consists of particles having an average diameter in a range from about 100 μm to about 300 μm.
11. The method of claim 1 , wherein the calcium phosphate consists of particles having an average diameter in a range from about 1000 μm to about 2000 μm.
12. The method of claim 1 , wherein the calcium phosphate consists of particles having an average diameter in a range from about 250 μm to about 1000 μm.
13. The method of claim 1 , where the calcium phosphate is β-tricalcium phosphate.
14. The method of claim 1 , wherein the calcium phosphate has a porosity greater than about 50%.
15. The method of claim 1 , wherein the calcium phosphate has a porosity greater than about 90%.
16. The method of claim 1 , wherein the composition has a porosity that facilitates cell migration into the calcium phosphate.
17. The method of claim 16 , wherein the porosity comprises macroporosity.
18. The method of claim 1 , wherein the composition is resorbable such that at least 90% of the calcium phosphate is resorbed within one year of being implanted.
19. The method of claim 1 , wherein the incorporated liquid is adsorbed or absorbed to the biocompatible matrix.
20. The method of claim 1 , wherein the composition is flowable.
21. The method of claim 1 , wherein the matrix consists of the particles of the porous calcium phosphate.
22. The method of claim 21 , wherein the calcium phosphate has a porosity greater than 90%.
23. The method of claim 21 , wherein the PDGF comprises PDGF-BB or a fragment thereof, wherein the fragment 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, wherein the composition has a porosity that facilitates cell migration into the composition.
24. The method of claim 1 , wherein the matrix consists of the particles of the porous calcium phosphate and collagen.
25. The method of claim 24 , wherein the PDGF comprises PDGF-BB or a fragment thereof, wherein the fragment 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, wherein the calcium phosphate has a porosity greater than about 50%.
26. The method of claim 24 , wherein the PDGF comprises PDGF-BB or a fragment thereof, wherein the fragment 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, wherein the calcium phosphate has interconnected pores, and wherein the composition has a porosity that facilitates cell migration into the composition.
27. The method of claim 24 , wherein the collagen comprises Type I collagen.
28. The method of claim 24 , wherein the ratio of calcium phosphate:collagen is about 80:20.
29. The method of claim 1 , wherein applying the composition comprises injecting the composition into the vertebral body.