Toxicity Study of Recombinant Human Platelet-Derived Growth Factor-BB Hydrated Bovine Type I Collagen in Decorated Femur Model in Rabbits—a Safety Study Model for Rotator Cuff Repair

摘要

The attachment site of the supraspinatus tendon and decorticated humeral head is the site of healing for rotator cuff repair. Based on FDA guidelines for local safety, a decorticated femur model in rabbits was utilized to approximate the delivery of the type I collagen bovine matrix hydrated with rhPDGF-BB. Under the conditions of this study, there were no specific adverse systemic, local histopathology or toxicity observations attributed to the type I collagen matrix hydrated with rhPDGF-BB following 1 and 6 weeks post-bilateral implantation. .