Bio-artificial liver approved for clinical trials in China
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A stem-cell-based artificial liver created by researchers at the Southern Medical University has now been approved for clinical trials by regulators in China. If the problems are cleared successfully, the novel approach could help millions of people battling liver failure worldwide, the South China Morning Post (SCMP) reported.
Liver failure is when the liver stops working abruptly due to an infection or prolonged exposure to substances such as medications or alcohol. According to some estimates, China logs nearly one million liver failure cases yearly, which does not have treatment but only ways to manage the condition.
A liver transplant is the only way to overcome this condition. Still, hurdles such as the lack of sufficient donors, high costs of surgery, and the need for lifelong immunosuppressants for the recipient make it an option for a minimal number of benefactors.
What does the artificial liver do?
The concept of an artificial liver has been around for more than five decades and is similar to what patients are offered when their kidneys fail. The liver is crucial for maintaining bodily health since it removes toxins from the body.
An artificial system relies on methods such as filtration or adsorption to remove toxins. Still, the process has side effects and requires the patient to be given plasma - the component of blood without cells.
On the other hand, a bioartificial liver works much like a natural liver since it requires plasma. Work on this was initiated in the 1980s but has not reached commercial success.
Gao Yi, executive director of the Translational Medicine Centre at Zhujiang Hospital of Southern Medical University, began his research in 1996, and the stem-cell-based bioartificial liver was recently approved by the regulators in China for human trials.
How is this bioartificial liver different?
The artificial device is located outside the body and, in addition to detoxification, performs essential tasks such as synthesizing enzymes necessary for digestion and growth.
The bioreactor system consists of a hollow fiber membrane that grows stem cells and is pumped back into the patient's bloodstream. Inside the body, these cells help regenerate the liver tissue and reverse the damage caused by inflammation.
The research team studied its approach in animal models such as mice, pigs, and monkeys, where it found that the bioartificial liver improve survival rate to 87.5 percent as against 17 percent with conventional approaches.
Replicating the success in human trials is a significant challenge, though. The pioneer of this technology is Vital Therapies, a US-based company that has conducted 11 clinical trials over two decades. Its product, dubbed Extracorporeal Liver Assist System (ECLS), has not received approvals for commercial rollout after results from Phase III trials were not up to the mark.
In China, Wuhan-based Togo Meditech has also conducted multiple trials, while Gao is teaming up with Qian Hui Biotech in Guangzhou to take the bioartificial liver commercial. If these companies do show promising results, treatment of liver failure will soon become an option for millions worldwide.
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