Injectable biomaterials and vertebral endplate treatment for repair and regeneration of the intervertebral disc.

The objectives of augmentation of the nucleus pulposus following disc removal are to prevent disc height loss and the associated biomechanical and biochemical changes. Flowable materials may be injected via a small incision, allowing minimally invasive access to the disc space. Fluids can interdigitate with the irregular surgical defects and may even physically bond to the adjacent tissue. Injectable biomaterials allow for incorporation and uniform dispersion of cells and/or therapeutic agents. Injectable biomaterials have been developed that may act as a substitute for the disc nucleus pulposus. Our work has focused on the evaluation of a recombinant protein copolymer consisting of amino acid sequence blocks derived from silk and elastin structural proteins as an injectable biomaterial for augmentation of the nucleus pulposus. This implant, NuCoretrade mark Injectable Nucleus is being developed by Spine Wave (Shelton, CT). The NuCoretrade mark material is comprised of a solution of the protein polymer and a polyfunctional cross-linking agent. The material closely mimics the protein content, water content, pH and complex modulus of the natural nucleus pulposus. Extensive mechanical testing, biocompatibility and toxicology testing have been performed on the material. Characterization studies indicate that the NuCoretrade mark Injectable Nucleus is able to restore the biomechanics of the disc following a microdiscectomy. Extensive biomaterial characterization shows the material to be non-toxic and biocompatible. The mechanical properties of the material mimic those of the natural nucleus pulposus. Thus NuCoretrade mark Injectable Nucleus is suitable to replace the natural nucleus pulposus following a discectomy procedure. Human clinical evaluation is underway in a multi center clinical study on the use of the material as an adjunct to microdiscectomy. Further clinical studies of the use of NuCoretrade mark Injectable Nucleus for treatment of early stage degenerative disc disease are planned in the near future. On-going efforts are characterizing the use of the material as a cell delivery vehicle for disc repair and reconstruction. Related development efforts are exploring methods for repair and regeneration of the cartilage endplate that are implemented to enhance the host-implant interface. Prior to the introduction of the above-mentioned biomaterial, our work proposes to utilize a process for the treatment of the vertebral endplates. The goal of this process is to restore the endplates as closely as possible to their natural state prior to disease or degeneration. The nature of the treatment will depend upon the form of the endplate degeneration and on the type of scaffolding that is intended to be introduced in the nuclear cavity. Endplate therapy is a potential means of enhancing biomaterial integration and cell survival, but remains a long-term and currently untested methodology.