The present invention relates to a novel bone graft and methods for producing the graft. The bone graft can be used for surgical, plastic and/or cosmetic bone replacement for a patient in need thereof. The bone graft is made of a scaffold or matrix of sheet material having a 3-dimensional pattern of a continuous network of voids and/or indentations for enhancing new bone growth.
1. A method for producing a bone graft, comprising the steps of
providing at least two bone matrix scaffolds, each bone matrix scaffold fabricated having at least one sheet exposed to microgravity over its development, wherein said at least one sheet material forms a macrostructure developed under microgravity having a substantially continuous network and voids with enhanced tensile loading when exposed to normal gravitational forces wherein bone cell attachment under normal gravitational forces, loading, and integration will all respond to a dynamic tension of subsequent compressive loading because each of the at least two bone matrix scaffolds form an engineered static structure having at least one sheet exposed during development to microgravity and inherent porosity of the scaffold to facilitate bone matrix enhancement;
connecting said at least two bone matrix scaffolds using fibers to produce the bone graft without cells; and
depositing of osseous material and/or chondral material with or without cells on said bone graft, wherein the engineered static structure has enhanced material properties that are stimulated by the tensile loading under normal gravitational forces.
2. The method according to claim 1 , wherein said fibers comprise at least one polymer and/or a mixture of polymers.
3. The method according to claim 2 , wherein said at least one polymer is a copolymer having carboxylic acid groups and/or amine groups.
4. The method according to claim 2 , wherein said at least one polymer is a conductive polymer selected from polypyrrole, polyaniline, polyacetylene, polythiophene, polyurethane as a bioresorbable, net neutral charge material and mixtures thereof.
5. The method according to claim 1 , wherein said fibers are collagen fibers.
6. The method according to claim 1 , wherein said fibers are non-aldehyde cross-linked type I collagen.
7. The method according to claim 5 , wherein said collagen is chemically cross-linked with nordihydroguaiaretic acid.
8. The method according to claim 1 , wherein said depositing of osseous and/or chondrial material on the bone graft includes incubating the deposited osseous and/or chondrial material with cells for a predetermined period of time.
9. The method according to claim 8 , wherein said cells are selected from the group of living cells and recombinant cells, chondrocytes, growth factor producing cells including TGF-producing cells, and osteoblasts.
10. The method according to claim 8 , further comprising removing said cells.
11. The method according to claim 1 , further comprising shaping the graft.
12. The method according to claim 11 , wherein the shaping is performed by a method comprising three dimensional printing, cutting, moulding and/or pressing.
13. The method according to claim 11 , wherein the graft is shaped in the form of a facial and/or cosmetic surgery graft.
14. The method according to claim 13 , wherein the graft is shaped in a patient specific form.
15. The method according to claim 1 , further comprising providing osteoinductive substances including proteins, to said graft.
16. The method according to claim 15 , wherein said osteoinductive substances are bone specific growth factors.
17. The method of claim 1 comprising the steps of; surgical, plastic and/or cosmetic bone replacement for a patient, comprising providing a graft and implanting said graft into said patient.
18. The method according to claim 17 , wherein said implanting is performed during cartilage, bone, joint, and/or articular cartilage repair and/or replacement.
19. The method according to claim 17 , wherein said implanting comprises the direct implantation into the matrix of the bone to be replaced.
20. The method according to claim 17 , wherein said providing of said graft further comprises shaping the graft.
21. The method according to claim 20 , wherein said shaping is performed by a method comprising printing, cutting, moulding and/or pressing.
22. The method according to claim 20 , wherein said graft is shaped in the form of a facial and cosmetic surgery graft.
23. The method according to claim 20 , wherein said graft is shaped in a patient-specific form.