Transdiscal administration of specific inhibitors of pro-inflammatory cytokines
View Patent ↗The present invention relates to injecting a high specificity cytokine antagonist into a diseased intervertebral disc.
1. A method of inhibiting degeneration of an extracellular matrix of a nucleus pulposus of an intervertebral disc having a degenerating nucleus pulposus and an annulus fibrosus in a patient in need thereof, comprising transdiscally administering into the degenerating nucleus pulposus an effective amount of a formulation comprising a highly specific cytokine antagonist that inhibits tumor necrosis factor-α (TNF-α), wherein said highly specific cytokine antagonist is released from a sustained release device comprising a hydrogel, thereby effectively inhibiting the degeneration of the extracellular matrix of the degenerating nucleus pulposus of the intervertebral disc.
2. The method of claim 1 , wherein said highly specific cytokine antagonist is a monoclonal antibody.
3. A method of inhibiting degeneration of an extracellular matrix of a nucleus pulposus of an intervertebral disc having a degenerating nucleus pulposus in a patient in need thereof, comprising transdiscally administering into the degenerating nucleus pulposus an effective amount of a formulation comprising infliximab, wherein said infliximab is released from a a sustained release device comprising a hydrogel, thereby effectively inhibiting the degeneration of the extracellular matrix of the degenerating nucleus pulposus of the intervertebral disc.
4. The method of claim 2 , wherein said monoclonal antibody binds membrane-bound TNF-α.
5. The method of claim 2 , wherein said monoclonal antibody binds soluble TNF-α.
6. The method of claim 1 , wherein said highly specific cytokine antagonist is released from said formulation by its diffusion through said sustained delivery device.
7. The method of claim 1 , wherein said highly specific cytokine antagonist is released from said formulation by biodegradation of said sustained delivery device.
8. The method of claim 1 , wherein the sustained release device provides controlled release.
9. The method of claim 1 , wherein the sustained release device provides continuous release.
10. The method of claim 1 , wherein the sustained release device provides intermittent release.
11. The method of claim 1 , wherein the sustained release device comprises a biosensor.
12. The method of claim 1 , wherein the sustained release device comprises a plurality of microspheres.
13. The method of claim 1 , wherein said sustained release device is adapted to remain in said intervertebral disc for at least 1 month.
14. The method of claim 13 , wherein said sustained release device is adapted to remain in said intervertebral disc for at least 2 months.
15. The method of claim 14 , wherein said sustained release device is adapted to remain in said intervertebral disc for at least 6 months.
16. The method of claim 1 , wherein the formulation is provided closely adjacent to the outer wall of the annulus fibrosus.
17. The method of claim 1 , further comprising removing a portion of the nucleus pulposus prior to administering an effective amount of said formulation.
18. The method of claim 1 , wherein said formulation is administered in a volume of between 0.03 ml and 1.0 ml.
19. A method of treating degenerative disc disease in an intervertebral disc having a nucleus pulposus and an annulus fibrosus in a patient in need thereof, comprising transdiscally administering into an intervertebral disc an effective amount of a formulation comprising a highly specific cytokine antagonist that inhibits tumor necrosis factor-α (TNF-α), wherein said highly specific cytokine antagonist is (a) administered in an amount effective to inhibit degradation of an extracellular matrix of the nucleus pulposus and (b) released from a sustained release device, wherein said sustained release device comprises a hydrogel, thereby effectively treating the degenerative disc disease in the intervertebral disc.