Compositions and Methods for Treating Bone

Abstract

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.