Primary human hepatocytes (PHH) are one of the most important cells in the body. They predict the sensitivity to drugs and toxins, are critical in understanding disease, and offer an alternative treatment to liver transplantation. If only they were readily available. The current supply of PHH is completely dependent on organ donation, and only those livers not healthy enough for transplantation. This limits the opportunities to utilize these critical cells. Until now.
A healthy liver is responsible for many bodily functions, including processing the blood to clean out harmful substances and toxins, synthesis of important blood components (e.g., clotting factors), making bile for the digestion of food, and storage of nutrients. An unhealthy liver cannot effectively perform these tasks, causing damage to the human body that can impact multiple systems and organs, increase the chance of infections, and more.
A liver can be damaged by several factors, including genetics, nutrition, viruses, and one’s environment, causing serious disease. Once liver disease has advanced and become severe enough, it can lead to liver failure. Liver failure can happen suddenly in patients with or without preexisting liver disease, or it can be the result of damage over a long period of time. All types of liver failure have limited options for treatment.
The sensitivity of the liver to harmful substances and toxins makes its cells ideal for screening for adverse effects. The U.S. FDA recommends the use of human primary hepatocytes as the standard model for drug metabolism studies and has provided guidelines for use in drug toxicity and drug development studies. Due to the limited availability and variable quality of the cells currently accessible, this critical resource can be the source of delays and inconsistent test results.
Currently, the only curative treatment for liver failure is a liver transplant. According to the U.S. Department of Health and Human Services, over 11,000 people in the U.S. are currently on the organ transplant waitlist for a liver, and approximately 9,000 people will receive liver transplants per year.
Primary human hepatocytes offer a potential alternative treatment to liver transplantation. These cells may be able to effectively treat liver failure as a part of an external liver assist device or through direct cellular transplant therapy. However, there is currently no clinically safe and consistently available source of primary human hepatocytes to enable these therapeutics at scale. With over 50,000 deaths attributed to liver failure each year in the United States, a better solution is necessary to meet this unmet need.
Cytotheryx has the platform technology to advance those therapies and enable other critical research and development to discover new approaches to treat liver disease.
In addition to the use of primary human hepatocytes in drug testing and the opportunity for their use in treating liver failure, liver cells can be used for numerous other applications. The liver plays a vital role in the human body, and damage to or disease of the liver can have wide-reaching consequences on the entire body, from the brain to the digestive system and beyond. Given the importance of the liver and its impact on the body, primary human hepatocytes could be useful for disease-specific research, personalized medicine, gene and cell therapy, and drug development.
With our proprietary platform technology, Cytotheryx can propagate large-scale, high-quality, dependable, and accessible primary human hepatocytes for drug discovery and disease-specific research, as well as in developing new therapeutics, standardizing and streamlining the process. The current research and future clinical applications require a high-quality, consistent, reliable source of liver cells to advance opportunities to impact the lives of many. Cytotheryx intends to provide the new gold standard of primary human hepatocytes for use in preclinical toxicology and metabolic safety testing in drug development, for the advancement of disease-specific research, and ultimately, to enable life-changing and life-saving therapeutics for those with liver disease, liver failure, rare diseases, and beyond.