Cellularized bone grafts for point-of-care complex craniofacial reconstructions

DESCRIPTION (provided by applicant): EpiBone is a company engineering living, anatomically precise and functionally mature bone grafts from autologous stem cells derived from fat aspirates. In the United States alone, there are over 400,000 emergency visits per year due to facial trauma, with ~20% of facial fractures being complex and involving more than one bone. Our goal with this SBIR is to develop the epiBone-CMF product: a unique class of stem cell- infused grafts that can be prepared within lt7 days and are thus suitable for trauma patients requiring cranio- maxillofacial (CMF) repair. In past research, we have established a technology for engineering anatomically shaped living bone grafts using our proprietary bioreactor, stem cells and decellularizedbone scaffolds, and showed excellent bone healing in a porcine model of craniofacial repair with grafts conditioned for 3 weeks in vitro. We now propose to establish rapid bioreactor conditioning of the cells in scaffolds, in order to develop a produc