Mesenchymal cell-based soft fusion as a biological intervertebral disc replacement
View Patent ↗The invention comprises a combination of biological elements that will naturally remodel in vivo based on applied mechanical forces. The final composition will possess mechanical properties similar to cartilage or a disc, and significantly less stiff than bone or implants comprised of metals or plastics. The equilibrium stress conduction will minimize unnatural forces on neighboring healthy discs.
1. A method of creating a fusion between vertebral bodies, the method comprising the steps of:
removing a portion of an intervertebral disc;
macerating, after the removing, the portion of the intervertebral disc to create disc fragments;
combining the disc fragments with mesenchymal or progenitor cells, a scaffold, and optionally a binding agent to form a fusion composition;
loading the fusion composition within an area or a junction between vertebral bodies; and
subjecting the fusion composition to a level of pressure and force to promote fusion between the vertebral bodies of a patient.
2. The method of claim 1 , wherein the scaffold is a rigid scaffold.
3. The method of claim 1 , wherein the scaffold is a porous scaffold.
4. The method of claim 1 , wherein the scaffold comprises hydroxyapatite.
5. The method of claim 1 , wherein the scaffold is comprised of calcium phosphate.
6. The method of claim 1 , wherein the binding agent comprises fibrin.
7. The method of claim 1 , wherein the fusion composition has a compressive strength of less than 10 MPa.
8. The method of claim 1 , wherein the fusion composition has a tensile strength of less than 12,000 MPa.
9. The method of claim 1 , further comprising:
wherein the disc fragments, the mesenchymal or progenitor cells, and optionally the binding agent form a soft fusion mass; and
wherein the soft fusion mass has a compressive strength between 0.1 MPa and 10 MPa.
10. The method of claim 1 , further comprising:
wherein the disc fragments, the mesenchymal or progenitor cells, and optionally the binding agent form a soft fusion mass; and
wherein the soft fusion mass has a tensile strength between 6.5 MPa and 12,000 MPa.
11. The method of claim 1 , further comprising:
wherein the disc fragments, the mesenchymal or progenitor cells, and optionally the binding agent form a soft fusion mass; and
wherein the soft fusion mass further comprises autologous bone marrow concentrate, allograft cancellous bone chips, and platelet poor plasma that has been clotted with thrombin.
12. A fusion composition comprising:
mascerated fragments of a spinal disc;
mesenchymal or progenitor cells;
a scaffold;
wherein said composition is used to promote fusion between vertebral bodies and form a load bearing mass; and
wherein the fusion composition has a compressive strength of less than 10 MPa.
13. The fusion composition of claim 12 , wherein the scaffold is comprised of calcium phosphate.
14. The fusion composition of claim 12 , further comprising a binding agent.
15. The fusion composition of claim 14 , wherein the binding agent comprises fibrin.
16. The fusion composition of claim 12 , wherein the fusion composition has a tensile strength of less than 12,000 MPa.
17. The fusion composition of claim 12 , further comprising wherein the disc fragments, the mesenchymal or progenitor cells, and optionally a binding agent form a soft fusion mass.
18. The fusion composition of claim 12 , further comprising:
wherein the disc fragments, the mesenchymal or progenitor cells, and optionally a binding agent form a soft fusion mass; and
wherein the soft fusion mass has a tensile strength between 6.5 MPa and 12,000 MPa.
19. The fusion composition of claim 12 , further comprising:
wherein the disc fragments, the mesenchymal or progenitor cells, and optionally a binding agent form a soft fusion mass; and
wherein the soft fusion mass further comprises autologous bone marrow concentrate, allograft cancellous bone chips, and platelet poor plasma that has been clotted with thrombin.