EPIBONE, INC. — Department of Health and Human Services SBIR Phase II: NIDCR

Description

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 Each year in the United States alone over bone reconstruction procedures are performed Facial fractures affecting the nasal area zygoma maxillary complex orbital area and mandible represent more than of all fractured facial bones and of facial fractures are complex and involving more than one bone Craniomaxillofacial CMF reconstruction is a significant challenge due to the complex bone geometries and the need to restore both the aesthetics and function for large defects Our goal is to produce bone tissue substitutes capable of significantly improving the current standards for bone replacement and reconstruction Our product EpiBone CMF is a tissue engineered patient specific living engineered bone generated from autologous adipose derived mesenchymal stem cells ADSCs cultured in a bioreactor system In past research we have established a technology for engineering anatomically shaped living bone grafts using our proprietary bioreactor stem cells and decellularized bone scaffolds We showed excellent bone healing in a porcine model of craniofacial repair with grafts conditioned for weeks in vitro We now propose to build on our previous experience to establish our technologyandapos s feasibility for repairing one of the most frequently needed bones in the head and face the zygomatic arch Our goal is to evaluate EpiBone graft safety host response and efficacy functional integration and bone remodeling over months implantation in a zygomatic arch model in pigs The graft will be produced by infusing stem cells isolated from a sample of the patientandapos s fat tissue and expanded in culture into decellularized bone scaffolds A key component of the production process is our bioreactor which will be used for cell seeding and conditioning We propose that the duration of the osteogenic induction inside the bioreactor plays a fundamental role in determining the quality of the final product We thus plan on comparing treatment of pigs divided in experimental groups for which grafts will be subjected to and weeks of osteogenic induction prior to implantation and comparing to scaffold controls no cells and no treatment Optimization of the timing of osteogenic induction in our bioreactor will lead to improved performance of our product and give more insights to its mechanism of action and downstream long term effects The evaluation of EpiBone graft toxicology clinical pathology and pharmacology proposed here is key to providing the safety and efficacy assessments that are requisite for our product to become a candidate for Phase I Clinical Trials in humans Successful completion of the proposed research will bring our product closer to its clinical application which has the potentia to revolutionize the current approach to bone repair PUBLIC HEALTH RELEVANCE Over US patients per year suffer complex cranio maxillofacial CMF fractures for which reconstruction is a significant challenge due to the complex bone geometries and the need to restore both the aesthetics and function In this SBIR Phase II proposal EpiBone proposes to evaluate their unique class of anatomically precise living bone grafts which are prepared by infusing autologous adipose derived mesenchymal stem cells ADSCs into bone scaffolds cultured in a bioreactor system We propose to build on our previous experience to establish our technologyandapos s feasibility for repairing one of the most frequently needed bones in the head and face the zygomatic arch cheek bone Our goal is to evaluate EpiBone graft safety host response and efficacy functional integration and bone remodeling over months implantation in a zygomatic arch model in pigs The outcomes of this study will be the starting point for human studies of anatomically shaped bone grafts and if successful will lead to a new class of therapies with better tissue integration reduction in follw up surgeries and improved patient comfort