US-based bioprinting company Organovo has unveiled plans to 3D print human liver tissue for direct transplantation to patients.
Organovo’s exVive3D bioprinted liver tissue has been available to researchers for drug testing since November 2014. Now the company focuses on a program to develop bioprinted therapeutic tissue for human liver transplants. Preclinical studies of implanted tissue in animal models showed engraftment, vascularisation and sustained functionality, including stable detection of liver-specific proteins and metabolic enzymes.
In a recent press release the company outlines that approximately 17,000 patients are currently on the US liver transplant waiting list, with only 6,000 liver transplants performed each year. With a market opportunity of over $ 3 billion, Organovo intends to submit an Investigational New Drug application to the US Food and Drug Administration for its therapeutic liver tissue in three to five years. The development will focus on two initial areas: acute-on-chronic-liver failure in patients with liver disease and paediatric metabolic liver diseases, where bioprinted liver tissue patches might show therapeutic benefits.
“We’re excited to introduce an implantable bioprinted liver tissue as the first preclinical candidate in our therapeutic tissue portfolio, and see the early results as extremely promising,” comments Keith Murphy, CEO, Organovo. “The scientific and commercial progress we have already made with ExViveTM Human Liver Tissue in drug toxicity testing has given us a firm foundation upon which to build a larger tissue for transplant. Advancing our first therapeutic tissue into preclinical development is an important milestone for Organovo, and it speaks to the power of our technology platform in addressing multiple applications, including preclinical safety, disease modeling and tissue replacement products for surgical implantation. We believe that 3D bioprinted tissues have an opportunity to provide options for patients who suffer from liver disorders.”
Eric Michael David, M.D., J.D., chief strategy officer and executive vice president of preclinical development at Organovo adds: “Organovo’s approach is designed to overcome many of the challenges that cell therapies and conventional tissue engineering have struggled to address, including limited engraftment and significant migration of cells away from the live. In our preclinical studies, we deliver a patch of functional tissue directly to the liver, which integrates well, remains on the liver and maintains functionality. We believe our tissues have the potential to extend the lives of patients on liver transplant lists, or those who do not qualify for transplants due to other factors.”
Organovo continues early research on other potential tissues for therapeutic use and is also pursuing proof-of-concept for additional areas for its liver tissue.