Vanderbilt’s nHA-PTKUR cements were implanted in femoral plug defects in rabbits and the formation of new bone and cartilage was evaluated between 4-18 months. As expected, intramembranous bone formation was observed near the periphery of the cement at 4 months. Additionally, endochondral bone growth was observed in the interior of the cement at 12 months. Endochondral bone growth of nHA-PTKUR in response to oxidative degradation by infiltrating chondrocytes (i.e. cartilage cells) is anticipated to maintain structural support while promoting remodeling at a rate aligned with patient biology. Recently, Vanderbilt developed Good Laboratory Practice (GLP) manufacturing processes and stable packaging configurations for nHA-PTKUR BVFs and bone cements, and their materials have passed the cytotoxicity, sensitization, intracutaneous reactivity, pyrogenicity, and acute systemic toxicity ISO 10993 biocompatibility tests. You can read more about their study published in ACS Biomaterials Science & Engineering. Future studies will include a pivotal preclinical study to demonstrate substantial equivalence to predicate BVFs and bone cements and GMP manufacturing development to support a 510(k) regulatory filing and clinical trial.
About the Vanderbilt Center for Bone Biology:
The Vanderbilt Center for Bone Biology (VCBB) was created to investigate diseases of bone and mineral metabolism. Investigators associated with the VCBB are engaged in basic, translational, and clinical research in musculoskeletal health. The goal of VCBB is to unravel novel biological mechanisms and to develop new treatments and diagnostic tools that can improve the quality of life for patients with bone destruction due to disease or trauma. The project is led by Scott Guelcher, PhD, a Professor of Chemical and Biomolecular Engineering and Director of the Vanderbilt Center for Bone Biology. Craig Duvall, PhD, the Cornelius Vanderbilt Professor of Biomedical Engineering, leads the development of the thioketal technology.