EPIBONE, INC. — Department of Defense SBIR Phase II: DHA17-009

Description

In the U.S., >400,000 cartilage-related procedures are performed yearly. Cartilage lesions, left untreated, can progress to joint degeneration and osteoarthritis (OA). OA affects 20% of Americans with resulting costs surpassing the $130 billion per year. Among active military service members, OA is a leading cause of disability. Durable treatments that are suitable for point-of-care application are not currently available. For soldiers in the battlefield, this means long rehabilitation and poor long-term prognosis of joint function. This creates an urgent need for new treatment modalities. EpiBone aims to advance skeletal reconstruction with living tissue substitutes capable of regenerating and repairing defects. Our platform enables us to engineer living and functional cartilage from stem cell-derived building blocks. We here propose to develop a first-in-class allogeneic cell-based injectable product (EpiBone-AlloCar), that is both regenerative and suitable for off-the-shelf application. The initial Phase I award enabled us to establish the feasibility of our product by showing i) the efficacy of product in regenerating cartilage in an in vitro cartilage defect model, (ii) a lack of antigenicity of the allogeneic cells, and iii) maintenance of bioactivity and cell viability following cryopreservation. Our goal in Phase II is to optimize EpiBone-AlloCar towards clinical trial and