China: artificial liver based on human stem cells starts. A possible hope for millions
Chinese authorities have given the green light to clinical trials of an artificial liver based on stem cells, a development that could help millions of people fight liver failure.
A Chinese team has created a bioreactor for a bioartificial liver, a device outside the body that does the liver's job of detoxifying and synthesizing proteins and chemicals needed for digestion and growth.
Blood flows through the bioreactor system, which uses a hollow fiber membrane to grow stem cells and essential substances, which are then introduced into the patient's bloodstream and help them regenerate tissue and suppress liver damage caused by the inflammation. It is not a long-term replacement, but, for now, an essential short-term aid.
Similar membranes are widely used in other medical processes, such as dialysis, but this is the first time they have been used to grow stem cells and replace an essential organ. The purpose of the bioartificial liver is to help the diseased liver until it regenerates or until a suitable graft becomes available for transplantation.
Before gaining approval for clinical use, however, the innovative device must demonstrate that it can deliver results in several phases of clinical trials.
“In animal models involving pigs and monkeys, we observed that our method increased the survival rate from 17%, as observed with conventional treatments, to 87.5%,” said Gao Yi, executive director of the Center of Translational Medicine at the Zhujiang Hospital of Southern Medical University in Guangdong Province.
Millions of sick people who will be able to hope again
According to a report released this year by market consultancy Frost & Sullivan, 500,000 to 1 million newly diagnosed liver failure patients are diagnosed in China each year. We can speak of a number between 4 and 8 million new patients in the world who will now have more hope.
There is no drug that can cure this deadly disease, and conventional treatments are usually only able to temporarily manage the situation.
According to Jiao Xingyuan, professor and liver transplant specialist at the First Affiliated Hospital, liver transplant is the only effective treatment, but its use is limited by the shortage of liver donors, complex surgeries, high costs and by the need for lifelong immunosuppressants. This new therapy allows for now to cure some cases of inflamed liver or in general to lengthen the waiting time to obtain a suitable liver, or part of it.
Bioartificial livers, which function more like real livers due to their comprehensive functions and do not rely on plasma and extrinsic proteins, began to emerge in the 1980s. Gao began his field research in 1996. His was the first such project to be funded by the National Natural Science Foundation of China, he said.
But the technology may be on the verge of a breakthrough into commercial use.
A pioneer in this field is Vital Therapies, an American company that has conducted the largest number of clinical cases to date. Between 1999 and 2018, it collected data and results from 11 clinical trials of its Extracorporeal Liver Assist System (ELAD) involving approximately 600 patients. However, it was not approved for use by US regulators after the crucial Phase III trial failed.
In China, at least two biotech companies have entered the clinical trial phase. One of them, Wuhan-based Togo Meditech, has compiled results from dozens of cases in clinical trials.
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The article China: artificial liver based on human stem cells starts. A possible hope for millions comes from Economic Scenarios .
This is a machine translation of a post published on Scenari Economici at the URL https://scenarieconomici.it/cina-parte-il-fegato-artificiale-basato-su-cellule-staminali-umane-una-possibile-speranza-per-milioni/ on Mon, 18 Sep 2023 10:00:44 +0000.