Malleable, cryopreserved osteogenic compositions with viable cells
AssigneeNuVasive, Inc.
InventorsGregory Williams, Erik Erbe, Susan Lynn Riley, Timothy Moseley, Ali Ismailoglu
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Abstract
A bone graft composition comprising a viable, osteogenic cellular material combined with a viscous cryoprotectant that includes a penetrating cryoprotective agent and a non-penetrating cryoprotective agent. The viscosity of the cryoprotectant is such that the composition is malleable, cohesive and capable of being formed into desired shapes.
Claims14
A bone graft composition comprising:
- bone particles containing viable osteogenic cellular material native to the bone particles;
- a viscous cryoprotectant comprising at least one penetrating cryoprotective agent and at least one non-penetrating cryoprotective agent, wherein the at least one non-penetrating cryoprotective agent comprises alginate,
- wherein the viscous cryoprotectant comprises a concentration of alginate of 4% to 6%;
- and
- a demineralized bone matrix,
- wherein a volume ratio of the bone particles to the demineralized bone matrix is in a range from 5:2 to 53, and wherein the bone graft composition is homogenous and malleable,
- wherein a second volume ratio of the bone particles to the viscous cryoprotectant is from 5:2 to 2:1, and
- wherein at least seventy percent of the viable osteogenic cellular material is viable after storage in the viscous cryoprotectant at −80 degrees Celsius or lower for a period of fourteen days.
A method of preserving viability of a bone graft material, the method comprising:
- combining viable bone graft material with a demineralized bone matrix, wherein a volume ratio of the viable bone graft material to the demineralized bone matrix ranges from 5:2 to 5:3 and wherein the viable bone graft material contains viable osteogenic cells inherent thereto;
- and
- combining the viable bone graft material and the demineralized bone matrix with a viscous cryoprotectant into a homogenous composition for preserving the viability of the viable bone graft material, wherein the viscous cryoprotectant includes at least one non-penetrating cryoprotective agent and at least one penetrating cryoprotective agent, wherein the at least one non-penetrating cryoprotective agent comprises alginate,
- wherein a second volume ratio of the viable bone graft material to the viscous cryoprotectant is from 5:2 to 2:1,
- wherein the viscous cryoprotectant comprises a concentration of alginate of 4% to 6%, and wherein at least seventy percent of the viable osteogenic cellular material is viable after storage in the viscous cryoprotectant at −80 degrees Celsius or lower for a period of fourteen days.
The method claim of 8, wherein the viable bone graft material is from viable cortical bone, and the demineralized bone matrix is from viable cancellous bone.
The method claim of 8, wherein the non-penetrating cryoprotective agent further comprises one or more of hyaluronic acid, hydroxyethyl starch, methylcellulose, carboxymethylcellulose, hydroxymethylcellulose, polyvinylpyrrolidone, polyethylene glycol, chitosan, and glycerol.
The method claim of 8, wherein the penetrating cryoprotective agent is one of dimethyl sulfoxide, glycerol, propylene glycol, ethylene glycol, propanediol, or a combination thereof.
Dependencies are inferred from the claim text.