BIOELASTIC MATERIAL TO PREVENT POSTLAMINECTOMY ADHESION

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This Phase I SBIR proposal to develop bioelastic materials for the prevention of post-laminectomy adhesions is in response to an NICHD, National Center for Rehabilitation Research (NCMRR) solicitation (SBIR 96-2) for "the development of materials that will enhance function and quality of life of individuals with physical disabilities." The physical disability resulting from intervertebral disc herniation constitutes the third most common condition for which worker disability is granted in the U.S. To improve the outcome of intervertebral disc laminectomy would be to improve the quality of life and rehabilitate function for many millions of disabled Americans. The particular bioelastic materials, elastic protein-based polymers comprised of repeating peptide sequences, to be used to exhibit extraordinary biocompatibility; they do not elicit fibrous capsule formation when implanted; they do not support cell attachment nor the adsorption of blood proteins that do, and they can be expected to slowly degrade with breakdown products being natural amino acids. The approach to the prevention of adhesions due to post-intervertebral discectomy involve: the development of two elastic protein-based polymers, their microbial production at high molecular weights and high yields with removal of endotoxins, the sample preparation in terms of elastic sheets and viscoelastic gels, the utilization of the rabbit as the animal model for discectomy at the lumbar spine region using the sheets to cover the midline dural sac and the gel to protect the exiting nerve roots from scarring, and the evaluation of peridural scarring and the presence of inflammatory and pain markers such as interleukin-1 and substance P by means of antibody probes on the histological sections.