Development of an in vitro system of human hepatic steatosis.

Period of Performance: 04/01/2015 - 09/30/2015


Phase 1 SBIR

Recipient Firm

Hemoshear, LLC
Principal Investigator


DESCRIPTION (provided by applicant): Non-alcoholic fatty liver disease (NAFLD) is a rapidly emerging public health crisis, affecting up to 75% of Type 2 diabetics and 95% of obese individuals. Glucose and insulin regulate de novo lipogenesis in the liver. Glucose and insulin regulate de novo lipogenesis in the liver. High glucose and insulin in human diabetics and animal models stimulate fat buildup in the liver that progresses to steatohepatitis. However there are no in vitro hepatocyte models that possess an adequate insulin-glucose response to induce steatohepatitis through a similar signaling pathway. HemoShear is a biotechnology research company that utilizes patented methodologies (US 7,811,782) to restore in vivo biology and responsiveness to primary cells in vitro. In 2014, HemoShear received the Tibbetts SBIR Award from the Small Business Administration for commercialization of innovation. In the HemoShear primary hepatocyte system, the presence of high glucose and insulin results in de novo hepatocyte lipogenesis and lipid accumulation histologically similar to primary human hepatocytes from a steatotic liver. This is unprecedented. The purpose of this Phase I SBIR is to further investigate induction of steatosis and progressive steatohepatitic changes in response to known risk factors at clinically relevant levels within HemoShear's human primary hepatocyte system, providing the framework a much needed platform to assess the efficacy of drugs and biomarkers under development, identify new targets and biomarkers and support investigative toxicology in steatohepatitis