Ex-vivo production of human demineralized bone matrix
AssigneeOsteosphere, LLC
InventorsMark S.F. Clarke, Mark Brinker, Alamelu Sundaresan
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Abstract
The present disclosure provides ex vivo-derived human demineralized bone matrix. The bone matrix is produced using mineralized three-dimensional bone constructs. The bone constructs are obtained by culturing osteoblasts and osteoclast precursors under randomized gravity vector conditions. Preferably, the randomized gravity vector conditions are obtained using a low shear stress rotating bioreactor, such as a High Aspect Ratio Vessel (HARV) culture system. The ex vivo-derived human demineralized bone matrix of the disclosure can be used in, for example, orthopedic and periodontal procedures.
Claims7
A method for the ex vivo preparation of human demineralized bone matrix, the method comprising:
- (a) providing a plurality of mineralized three-dimensional bone constructs each comprising a spheroid of between about 200 μm and about 4 mm in diameter, the spheroid having an outer layer surrounding an inner core, wherein said outer layer comprises osteoclasts, wherein said inner layer comprises osteoblasts, osteocytes, or both osteoblasts and osteocytes embedded within a crystalline matrix, and wherein said crystalline matrix comprises calcium, phosphates, and carbonates;
- (b) mechanically disrupting said mineralized three-dimensional bone constructs in the presence of an acid;
- and
- (c) dessicating the preparation of step (b) to form said human demineralized bone matrix.
Dependencies are inferred from the claim text.