Methods for treatment of distraction osteogenesis using PDGF
View Patent ↗The present invention relates to compositions and methods for use in osteodistraction procedures. In one embodiment, a method of stimulating osteogenesis during and/or following bone distraction comprises providing a composition comprising a PDGF solution disposed in a biocompatible matrix and applying the composition to at least one site of bone distraction.
1. A method of stimulating osteogenesis in a bone distraction procedure comprising applying an effective amount of a composition comprising a platelet-derived growth factor (PDGF) solution disposed in a biocompatible matrix to at least one side of bone distraction;
wherein the PDGF solution comprises PDGF at a concentration ranging from about 0.1 mg/mL to about 1.0 mg/mL in a buffer, and the biocompatible matrix comprises i) a porous calcium phosphate, ii) collagen and a porous calcium phosphate, iii) an allograft, or iv) collagen and an allograft,
wherein the calcium phosphate or allograft comprises interconnected pores, and wherein the calcium phosphate or allograft comprises particles in a range of about 100 to about 5000 microns in size.
2. The method of claim 1 , wherein the composition is applied during the distraction phase of the osteodistraction procedure.
3. The method of claim 1 , wherein the composition is applied during the consolidation phase of the osteodistraction procedure.
4. The method of claim 1 , wherein the composition is applied during the distraction and consolidation phases of the osteodistraction procedure.
5. The method of claim 1 , wherein the method comprises accelerating bone consolidation following bone distraction.
6. The method of claim 1 , wherein the composition is applied to the site at least twice.
7. The method of claim 1 , wherein the biocompatible matrix comprises the porous calcium phosphate and collagen.
8. The method of claim 7 , wherein the calcium phosphate comprises β-TCP.
9. The method of claim 7 , wherein the calcium phosphate has a porosity greater than about 40%.
10. The method of claim 7 , wherein the calcium phosphate consists of particles in a range of about 1000 microns to about 3000 microns in size.
11. The method of claim 7 , wherein the calcium phosphate consists of particles in a range of about 100 microns to about 300 microns in size.
12. The method of claim 7 , wherein the biocompatible matrix is resorbable such that at least about 80% of the calcium phosphate is resorbed within about one year of being implanted.
13. The method of claim 7 , wherein the calcium phosphate is capable of absorbing an amount of the PDGF solution that is equal to at least about 25% of the weight of the calcium phosphate.
14. The method of claim 1 , wherein the PDGF is present in the solution at a concentration of about 0.3 mg/mL.
15. The method of claim 1 , wherein the biocompatible matrix has a porosity that facilitates cell migration into the composition.
16. The method of claim 1 , wherein the biocompatible matrix comprises collagen and β-TCP in a ratio of about 20:80.
17. The method of claim 1 , wherein the composition is injectable.
18. A method of performing an osteodistraction procedure comprising:
(a) partitioning a bone into a first bone segment and a second bone segment;
(b) moving at least one of the first and second bone segments to form a space between the first and second bone segments; and
(c) stimulating osteogenesis in the space,
wherein stimulating osteogenesis comprises applying an effective amount of a composition comprising a PDGF solution disposed in a biocompatible matrix to the space;
wherein the PDGF solution comprises PDGF at a concentration ranging from about 0.1 mg/mL to about 1.0 mg/mL in a buffer, and the biocompatible matrix comprises i) a porous calcium phosphate, ii) collagen and a porous calcium phosphate, iii) an allograft, or iv) collagen and an allograft,
wherein the calcium phosphate or allograft comprises interconnected pores, and wherein the calcium phosphate or allograft comprises particles in a range of about 100 to about 5000 microns in size.
19. The method of claim 18 , further comprising repeating steps (b) and (c) a number of times necessary to lengthen the bone a desired amount.
20. The method of claim 7 , wherein the calcium phosphate comprises particles in a range of about 250 to about 1000 microns in size.
21. The method of claim 7 , wherein the calcium phosphate comprises β-TCP, the PDGF comprises PDGF-BB, the PDGF is at a concentration of about 0.3 mg/mL, and the β-TCP has a porosity greater than about 40%.
22. The method of claim 21 , wherein the biocompatible matrix comprises collagen and β-TCP in a ratio of about 20:80.
23. The method of claim 22 , wherein the composition is injectable.