Type I coliagen has been used in a wide variety of medical applicationl One such example is the use of an injectable type collagen gel for the repair of dermatological defect or other soft tissue augmentation application; this material used solely as a subdermal implant , is isolated in soluble form from calf ski. However, the dermatological repair with this commercially available injectable soluble collagen is temporary, lasting at most three months; regular reapplication of soluble collagen is necessary to gain broader application of injectable collagen. It is clear that improvements to this product concept are necessary to gain broader application of injectable collagen. It was proposed in our phase I study that an injectable collagen matrix bead, combined with hyaluronic acid, would provide an alternative concept for soft tissue augmentation; in our phase I study, it was shown that the collagen/hyaluronic acid beads encourage cell attachment, cell growth, and production of new collagen. In addition, the microporous collagen matrix beads carry a higher density of cells than a non-porous gel. Phase II of this project is designed to test the safety and efficacy of the injectable collagen matrix beads created in the phase I study. Dermal implant studies using rats will be used for screening selected formulations, while small pigs will be used to determine the extent and longevity of the injectable collagen matrix beads compared to the commercially available soluble collagen. It is anticipated that these phase II studies will lead to the submission of an application to the FDA to allow clinical investigation of the material.
