Bone grafts and methods of making and using bone grafts

Abstract

Provided herein are bone grafts and methods of making and using the same, as well as products and kits that include such bone grafts. In particular, bone grafts are provided that include osteogenic stem cells in a mix of osteoinductive demineralized bone matrix and osteoconductive cortico-cancellous chips.

We claim: 
     
         1 . A bone graft comprising
 osteogenic stem cells, and   a mix of osteoinductive demineralized cortical fibers having a size in the range of 250 microns to 3 mm and osteoconductive cortico-cancellous chips having a size in the range of 0.05 to 1.5 mm, wherein the demineralized cortical fibers and cortico-cancellous chips are mixed at a ratio of 1:1.   
     
     
         2 . The bone graft of  claim 1 , wherein a concentration of the osteogenic stem cells in the bone graft is more than 20,000 cells/cc of final product. 
     
     
         3 . The bone graft of  claim 1 , wherein the demineralized cortical fibers are milled to a length to width ratio of 5:1 to 500:1. 
     
     
         4 . The bone graft of  claim 1 , wherein the demineralized cortical fibers are obtained by separating cortical bone from bone marrow, rinsing and milling the cortical bone to fiber, and treating the cortical fibers to adjust the pH of the water the fibers are in to between 6.5 and 7 to form the demineralized cortical fibers. 
     
     
         5 . The bone graft of  claim 1 , wherein the cortico-cancellous chips are obtained from fresh frozen condyles and milling the condyles using a bone mill to produce the cortico-cancellous chips. 
     
     
         6 . The bone graft of  claim 1  further comprising a freezing media and dimethyl sulfoxide. 
     
     
         7 . The bone graft of  claim 1 , wherein the bone graft is freeze dried. 
     
     
         8 . The bone graft of  claim 1 , wherein the bone graft is stored at a temperature between −80° C. and −180° C. 
     
     
         9 . A bone graft comprising
 osteogenic stem cells, and   a mix of osteoinductive demineralized bone matrix and osteoconductive cortico-cancellous chips.   
     
     
         10 . The bone graft of  claim 9 , wherein the demineralized bone matrix and cortico-cancellous chips are mixed at a ratio of about 1:1 to 2:1. 
     
     
         11 . The bone graft of  claim 9 , wherein a concentration of the osteogenic stem cells in the bone graft is more than 20,000 cells/cc of final product. 
     
     
         12 . The bone graft of  claim 9 , wherein the demineralized bone matrix is demineralized cortical fibers. 
     
     
         13 . The bone graft of  claim 12 , wherein the demineralized cortical fibers are milled to a length to width ratio of 5:1 to 500:1. 
     
     
         14 . The bone graft of  claim 12 , wherein the demineralized cortical fibers are obtained by separating cortical bone from bone marrow, rinsing and milling the cortical bone to fiber, and treating the cortical fibers to adjust the pH of the water the fibers are in to between 6.5 and 7 to form the demineralized cortical fibers. 
     
     
         15 . The bone graft of  claim 9 , wherein the cortico-cancellous chips are obtained from fresh frozen condyles and milling the condyles using a bone mill to produce cortico-cancellous chips having a size in the range of 0.05 to 1.5 mm. 
     
     
         16 . The bone graft of  claim 9  wherein the bone graft is freeze dried. 
     
     
         17 . The bone graft of  claim 9 , wherein the bone graft is stored at a temperature between −80° C. and −180° C. 
     
     
         18 . A method of promoting bone healing in a mammal comprising inserting the bone graft of  claim 9  into a mammal in need of said bone graft. 
     
     
         19 . A product comprising an implant and at least one bone graft according to  claim 9 . 
     
     
         20 . A kit comprising at least one bone graft according to  claim 9  or at least one component thereof, and at least one additional component selected from the group consisting of instructions for the preparation of the bone graft, one or more tools, devices, or other components to assist in making or using the bone graft.