Intervertebral disc (IVD) degeneration is one of the most prevalent causes of back/neck pain which often leads to disability for individuals of working age. Low back pain as a result of IVD degeneration is a common condition with a high impact on society, physically for the afflicted individual, as well as economically.
Current treatment methods for degeneration-induced low back pain are fusion, and total disc replacement. Both methods do not have a sufficiently high clinical efficacy and are too often accompanied by complications. Preferably, a degenerating disc should be restored to a healthy state, i.e. regeneration. Biological interventions have so far been unsuccessful. The invention introduces porcine notochordal cell matrix as a stimulant for IVD regeneration.
A protein extract isolated from the pig nucleus pulposus containing notochordal cells is solubilized and dissolved in a carrier solvent or formed as a gel. The solution can be injected into the core of the degenerated spinal disc using a very thin needle which avoids any damage to the outer disc annulus, providing an optimal scaffold for autologous tissue restoration. This device will be used as an injectable treatment for degenerative disc disease.
The method of making a notochordal cell matrix solution/gel for purposes of regeneration intervertebral disc have been set up and patented. The method has been shown to stimulate native or stem cells to proliferate and to induce important constituents of the IVD in an in vivo dog model for IVD degeneration. Seed funding of 550k has been secured, and the manufacturing has been transfered to a commercial CE certified partner. 3D biomechanical tests on humans have been initiated. Finally, the establishment of a Quality Management System is also in process.
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