Compositions and Methods for Treating Bone
The present invention relates to compositions, methods and kits for the treatment of bone particularly impaired or damaged bone.
1 . A method of treating bone comprising:
providing a composition comprising a PDGF solution disposed in a biocompatible matrix; and,
applying the composition to the bone, wherein the bone is a fractured bone, an osteoporotic bone, a weakened bone, or a bone susceptible to damage due to increased compensatory load.
2 . The method of claim 1 , wherein the composition further comprises a contrast agent, one or more biologically active agents, or a mixture thereof.
3 . The method of claim 1 , wherein the bone is a humerus, ulna, radius, femur, tibia, fibula, patella, ankle bone, wrist bone, carpal, metacarpal, phalangeal, tarsal, metatarsal, rib, sternum, vertebra, scapula, clavicle, pelvis, or sacrum.
4 . The method of claim 1 , further comprising:
applying the composition to orthopedic hardware; and,
inserting the orthopedic hardware into the bone.
5 . The method of claim 1 , wherein the PDGF is PDGF-AA, PDGF-BB, PDGF-AB, PDGF-CC, or PDGF-DD, or a mixture thereof.
6 . The method of claim 1 , wherein the PDGF is rhPDGF-BB or a fragment thereof.
7 . The method of claim 1 , wherein the PDGF is present in the solution at a concentration ranging from about 0.01 mg/ml to about 10.0 mg/ml.
8 . The method of claim 1 , wherein the biocompatible matrix comprises a bone scaffolding material.
9 . The method of claim 8 , wherein the bone scaffolding material comprises a calcium phosphate or bone allograft wherein the bone allograft is demineralized freeze-dried bone allograft or particulate demineralized bone matrix.
10 . The method of claim 8 , wherein the bone scaffolding material further comprises a biocompatible binder.
11 . The method of claim 10 , wherein the biocompatible binder comprises proteins, polysaccharides, nucleic acids, carbohydrates, or synthetic polymers, or mixtures thereof.
12 . The method of claim 10 , wherein the biocompatible binder is collagen.
13 . The method of claim 9 , wherein the calcium phosphate has a calcium/phosphorous atomic ratio ranging from 0.5 to 2.0.
14 . The method of claim 9 , where the calcium phosphate is β-tricalcium phosphate.
15 . The method of claim 14 , wherein the β-tricalcium phosphate comprises pores having diameters raging from about 1 μm to about 1 mm.
16 . The method of claim 14 , wherein the β-tricalcium phosphate has a porosity greater than about 25%.
17 . The method of claim 14 , wherein the β-tricalcium phosphate comprises particles and the particles have a size ranging from about 1 μm to about 5 mm.
18 . The method of claim 10 , wherein the biocompatible binder is present in an amount up to about 50 weight percent of the biocompatible matrix.
19 . The method of claim 1 , wherein the solution has a pH ranging from about 3.0 to about 8.0.
20 . A composition comprising:
a solution comprising PDGF;
a biocompatible matrix; and,
a contrast agent or one or more biologically active agents, wherein the solution is disposed in the biocompatible matrix
21 . The composition of claim 20 , wherein the PDGF comprises PDGF-AA, PDGF-BB, PDGF-AB, PDGF-CC, or PDGF-DD, or a mixture thereof.
22 . The composition of claim 20 , wherein the PDGF comprises rhPDGF-BB or a fragment thereof.
23 . The composition of claim 20 , wherein the PDGF is present in the solution at a concentration ranging from about 0.01 mg/ml to about 10.0 mg/ml.
24 . The composition of claim 20 , wherein the biocompatible matrix comprises a bone scaffolding material.
25 . The composition of claim 20 , wherein the bone scaffolding material comprises calcium phosphate or a bone allograft wherein the bone allograft is demineralized freeze-dried bone allograft or particulate demineralized bone matrix.
26 . The composition of claim 24 , wherein the bone scaffolding material further comprises a biocompatible binder.
27 . The composition of claim 26 , wherein the biocompatible binder comprises proteins, polysaccharides, nucleic acids, carbohydrates, or synthetic polymers, or mixtures thereof.
28 . The composition of claim 26 , wherein the biocompatible binder is collagen.
29 . The composition of claim 20 , wherein the solution has a pH ranging from about 3.0 to about 8.0.
30 . The composition of claim 25 , where the calcium phosphate comprises β-tricalcium phosphate.
31 . Orthopedic hardware comprising the composition of claim 20 .
32 . A kit comprising:
a first container comprising a solution comprising PDGF; and,
a second container comprising a biocompatible matrix.
33 . The kit of claim 32 , further comprising a bone scaffolding material.
34 . The kit of claim 33 , wherein the bone scaffolding material further comprises a biocompatible binder.
35 . The kit of claim 33 , wherein the bone scaffolding material comprises a calcium phosphate or bone allograft wherein the bone allograft is demineralized freeze-dried bone allograft or particulate demineralized bone matrix.