Source: SciPhi

Liver failure refers to the serious deterioration of liver function, which is a critical condition that often leads to serious dysfunction or decompensation of the body's synthetic, detoxification, metabolic and biotransforming functions. Common symptoms include jaundice, coagulation dysfunction, hepatorenal syndrome, hepatic encephalopathy, ascites and so on.

Existing conventional treatments include conventional drug therapy, mechanical artificial liver and liver transplantation. The first two methods of treatment are often unsatisfactory, and liver transplantation is the most effective treatment method at present, but this method faces limitations such as donor shortage, and scientists have been looking for more alternative methods.

Recently, Professor Gao Yi's team at Zhujiang Hospital of Southern Medical University has made important progress in the transformation research of combined bioartificial liver, and the world's first stem cell bioartificial liver drug combination product independently developed by the team has obtained the clinical trial approval of the National Medical Products Administration (NMPA). The official press release pointed out that this marks the rapid development of clinical research and industrialization of bioartificial liver in China.

(Source: Southern Medical University official website)

It is reported that this is also another milestone in the transformation research breakthrough after the transfer of 10 invention patents by the Zhujiang Hospital and Professor Gao Yi's team.

Gao Yi said in an interview that the experimental study results in the treatment of liver failure in large animals confirmed that the approved clinical trial of stem cell-based bioartificial liver treatment has significantly improved the survival rate, effectively suppressed systemic inflammatory response, and improved homeostasis. The stem cell bioartificial liver is expected to provide a new life-saving treatment system for patients with liver failure.

Bioartificial liver system is a kind of in vitro liver function support system, which has the functions of detoxification, synthesis, secretion and transformation of bioactive substances. The basic principle is that the patient's plasma can be bidirectional material exchange with human liver cells in the bioreactor through cardiopulmonary bypass, which can replace the liver work in a short time, and promote the regeneration and repair of the damaged liver, and the performance is closer to that of human liver cells.

During the development process, Gao's team conducted a large number of preliminary trials, and they found that in both the hepatectomy mouse model and the drug-induced pig liver failure model, the inflammatory mechanism is present in all liver failure processes with acute phase characteristics. Mesenchymal stem cells (MSCs) are a kind of pluripotent stem cells, which can inhibit liver damage caused by excessive inflammation, and play a role in immune regulation and tissue regeneration through cytokine secretion and exosome secretion.

Prof. Gao Yi (Source: Southern Medical University)

Therefore, the research team proposed for the first time the stem cell type bioartificial liver and constructed "mesenchymal stem cells for blood purification". According to a description in People's Daily, it consists of a pot of hollow fiber membrane bioreactors growing human mesenchymal stem cells (MSCs), and is treated through an artificial liver blood purification model based on a paracrine mechanism. In large animal models of liver failure used in pigs and monkeys, the stem cell bioartificial liver showed a very good therapeutic effect, with the survival rate increased from 17% to 87.5% compared with conventional treatment.

In fact, as an expert in hepatobiliary and pancreatic surgery who has been focusing on artificial liver research for a long time, Gao Yi's team developed the world's first combined bioartificial liver (principle prototype) as early as 2006, and subsequently proposed for the first time the concept of selecting appropriate cells to carry out stratification treatment of bioartificial liver according to different stages of acute liver failure, providing a new idea for the treatment of liver disease.

The clinical trial of the drug is expected to run for about two years, and if it goes well, it will accelerate the introduction of new treatments for patients with liver failure. In addition, the quality control of the production of stem cell bioartificial liver is also stable, and the research team is working with Guangdong Qianhui Biotechnology Company to promote commercialization.

Reference:
1.https://www.smu.edu.cn/info/1139/25499.htm2.https://www.smu.edu.cn/info/1241/25419.htm3.https://www.scmp.com/news/china/science/article/3234150/chinas-man-made-liver-therapy-game-changer-millions-battling-liver-failure-globally?module=lead_hero_story&pgtype=homepage