A Cell-Based Artificial Liver

The World Health Organization estimates that 10% of the world’s population has chronic liver disease, including 25 million Americans. In China alone half a million die of the disease each year.

The need for an artificial liver device able to remove toxins and improve immediate and long-term survival results is more critical today than ever before. Limited treatment options, a low number of donor organs, the high price of transplants and follow up costs, a growing base of hepatitis, alcohol abuse, drug overdoses, and other factors that result in liver disease all clearly indicate a strong need for an artificial liver device.

For 30 years the medical world has tried to create that life-saving device. Hepatocytes, or liver cells, are the key to a functioning bioartificial liver. But the liver is a complex organ: It takes in oxygen and nutrients, and returns metabolic byproducts to the plasma. It must regulate the balance of fluids, electrolytes, and glucoses. Plus it synthesizes albumin, globulins, and heparin; and filters out ammonia, toxins, and false neurotransmitters.

No machine has been invented that could do all that. And so scientists began looking at the obvious answer – replicate the liver cells themselves….

Our scientists stabilized liver cells to function outside the body. We put the PICM-19 through tough tests – splitting, culturing, and subjecting them to room temperature for days at a time. Unlike other cells, HepaLife’s liver cells remain fully functional and do not become tumorigenic or cancerous, despite years in continuous culture. The PICM-19 has now been in continuous culture for over two years without showing any change in function.

NIH says artificial liver assist device would be “most helpful”

In January, 2005, the NIH issued its widely reported Action Plan for Liver Disease Research. The Action Plan was backed by all 17 NIH institutes, including 250 liver disease experts.

That plan stated, in part, “In the area of acute liver failure, the primary goals of research should be in developing means to prevent acute liver failure and ameliorate its course….Most helpful would be an artificial or bioartificial liver assist device that could be used to sustain patients and serve as a bridge to liver transplantation, which is the only effective treatment that is currently available for fulminant hepatic failure.”

In May of 2006 the NIH issued an update on the first year’s progress. In it, they reiterated their goal “to develop a hepatic assist device or bioartificial liver and demonstrate its efficacy in acute liver failure.”

We at HepaLife Technologies hope to help meet that goal