LyGenesis Announces Four Peer-Reviewed Publications on its Organ Regeneration Technology

LyGenesis, Inc., a biotechnology company focused on regenerative medicine, announced today that four peer-reviewed papers have been published on its organ regeneration technology.

LyGenesis' lead development asset is liver regeneration, which was the focus of the first two papers. “Development of Ectopic Livers by Hepatocyte Transplantation into Swine Lymph Nodes” by Fontes et al. was published this month in Liver Transplantation, demonstrating that functional mini-livers could be grown using the lymph node as a bioreactor. In this swine model using surgically-induced liver injuries, liver cells were isolated from the animals and then transplanted into lymph nodes in the abdominal region of the animal. In 100% of the animals the transplanted liver cells engrafted into the lymph nodes, proliferated, and formed ectopic mini-livers, which had the same structure and function as native liver tissue. The cell transplant procedure was safe, well tolerated, and as expected, the amount of liver mass generated by the ectopic livers was proportional to the degree of the native liver's damage.

The second paper, “Ex Vivo Cell Therapy by Ectopic Hepatocyte Transplantation Treats Porcine Tyrosinemia Model of Acute Liver Failure” by Nicolas and colleagues was published in Molecular Therapy: Methods & Clinical Developments. In this study, a human liver disease (tyrosinemia Type I) was modeled in swine, and liver cells transplanted into lymph nodes were capable of forming ectopic livers that cured all of the animals of otherwise fatal liver disease. The engraftments were again shown to be safe and also structurally and functionally similar to native liver tissue.

“The development and FDA approval of novel therapies for life-threatening diseases requires a rigorous approach to preclinical studies and our ability to grow ectopic organs to support failing organs in patients is no exception," said Dr. Paulo Fontes, LyGenesis's Chief Medical Officer and former Director of the Liver Transplant Program, Starzl Transplant Institute at the University of Pittsburgh Medical Center. "Showing that our cellular therapy was able to safely and effectively induce organogenesis – the forming of a novel, well-vascularized organ within the body – in multiple models of liver disease in large animals was a crucial step toward beginning our forthcoming clinical trial for patients with end stage liver disease who are currently ineligible for standard liver transplantation.”