The overall objective of this research is to develop a biocompatible and biodegradable polymer matrix system for delivery of osteoblasts to the site of osseous defects in order to induce the formation of new osseous tissue. We have already shown that films prepared from a proprietary polymer system will support osteoblast growth in vitro. In this Phase I proposal, we intend to optimize the properties of the polymer matrix delivery system to support the growth of osteoblasts and their osteogenic characteristics in vitro, and to determine the conditions required for autologous osteoblasts supported on the polymer matrix delivery system to provide optimal osteoinduction in rabbits with non-healing bony defects. Polymer films with different compositions and material handling properties will be evaluated in cell cultures for their ability to support osteoblast growth and proliferation. The two most promising materials will be evaluated in a rabbit mandible critical size defect model over 3 months for rate and extent of bone formation using histomorphometric measurements. These studies will establish whether the autologous osteoblast polymer matrix delivery system can induce bone augmentation in vivo and provide information on the suitability of the product to be used as an alternative to convention methods of bone augmentation.
The replacement or augmentation of bone represents a large and growing market in dental applications such as implants, alveolar ridge augmentation, and craniofacial surgery, as well as orthopedic uses such as non-union fractures, hip replacements, and other boney defects. These applications represent a market well over $10 million in sales annually. The product developed by this research would provide a safer, less painful, and more predictable method than autografts for bone formation in large defects.
