Heavy!The world's first human embryonic stem cell source liver cells to treat liver failure success

Zhang Chunxiang, a reporter from Hunan Daily, Zhang Chunxiang, Zhang Ying Sun Yan

On August 25, news came from Xiangya Hospital of Central South University that the first patient of the treatment of the safety and clinical research of "human embryo stem cells to induce and differentiated hepatocytes to treat acute/slow acute liver failure". Cell therapy is proven to be safe and effective. This is also the first patient with liver failure for human embryonic stem cells for human embryonic stem cells.

(Photo: In early August, in Wuyang Town, Suining County, Shaoyang City, Mr. Chen received a condolences from his old classmates and smiled.)

my country is a major country of liver disease. The number of new liver diseases in the end of each year exceeds 6 million. Liver transplantation in situ is still the most effective treatment method, but the liver source is very scarce. The National Engineering Research Center of Human Stem Cell in Changsha, Hunan, successfully induced human embryo stem cells into liver cells, providing safe, stable, and sufficient cell sources for the treatment of end liver disease. The clinical cooperation with Xiangya Hospital is expected to break the liver failure Treatment bottleneck.

He became the first "crab eating" person three times a lot of artificial liver

Mr. Chen, who lives in Wuyang Town, Suining County, Shaoyang City, Hunan Province, is the first patient in the world for liver failure patients who have been treated with human embryo stem cells. In early August, less than a month before he was discharged from Xiangya Hospital, he had been able to walk for more than a kilometer journey and rushed to the town.

Mr. Chen is 39 years old and has a history of hepatitis B for nearly 16 years. He described himself that he had taken antiviral drugs since 2018, but at the end of 2021, "the medicine was stopped at the end of 2021." In April 2022, he began to have symptoms of fatigue, abdominal distension, poor appetite, severe skin and eye sclera of the whole body, severe yellow dyeing, urine yellowing and other symptoms. Bile tubeitis, the condition is critical.

In May, due to the rapid development of liver failure, he performed three consecutive artificial hepatic plasma replacement treatment, but the results were very small. He came to Xiangya Hospital for treatment. At this time, his father died of stomach cancer. "I can't even afford the burial fee!" Just when Mr. Chen was about to give up the healing, when he packed his luggage home, Professor Huang Yan, director of the Department of Infectious Medicine of Xiangya Hospital, found him and introduced the clinical scientific research on stem cells to treat liver failure. Essence "Although I have never heard of stem cells before, I hope that I will catch it." Mr. Chen recalled.

After the evaluation of the medical expert group and the research team, and fully communicating with the patients and their families, Mr. Chen accepted the treatment of two -person embryonic stem cell agent treatment on May 26th and 29th.

The effect is obvious, and Mr. Chen's family life appears to turn

(Photo: In May 2022, Mr. Chen received the treatment of human embryonic stem cells in the infection department of Xiangya Hospital.)

Huang Yan introduced that liver function and coagulation function are the most critical data to clinically determine the progress of the patient's liver failure. After the treatment, the total bilirubin value in Mr. Chen's liver function dropped from a maximum of 592.2umol/L to 143.4umol/L; the PTA was as low as 35.2%when the coagulation function was severely damaged, and the INR value was as high as 2.03. . 9%, INR1.36; the end-end liver disease index Meld score and liver cirrhosis index Child-PUGH scores have improved significantly.

More than a month after receiving stem cell treatment, Mr. Chen recovered well, with normal appetite, and was discharged smoothly. As of August 24, he had followed up 3 months after the treatment of stem cells, and the results of the eight visits were integrated. The cell therapy was safe and effective.

(Photo: In early August, Mr. Chen's limbs have obviously faded dark yellow.)

At present, Mr. Chen's eyeballs, nail beds, and limbs have obviously faded dark yellow. He felt that his mental state was good. He went out in the morning and evening to take a walk to exercise. Breakfast could eat two eggs and a bowl of noodles.

"I am a person who comes back from the edge of death, so cherish the present more." Mr. Chen said that he was famous in the town. He wanted to raise his body, and then Carry up the burden of your family by yourself.

Treatment mechanism: "universal cells" induces differentiation of liver cells

Professor Huang Yan, director of the infection department of Xiangya Hospital, who is responsible for the clinical study, introduced that liver failure is a severe liver damage caused by various factors. Rapid to death. China is a large country of liver disease. There are 120 million people with hepatitis B virus. The number of new liver diseases per year is more than 6 million. At present, liver transplantation is still the most effective treatment, but liver source is very lacking.

Professor Lu Guangzheng, director of the National Engineering Research Center of the Human Stem Cell, introduced that it was used to treat Mr. Chen's cell preparations, which originated from human embryonic stem cells. This is an internal cell group from the fertilized 5-6 days. It is also known as a magical "universal cell". It can expand infinitely in vitro and be induced to differentiate into almost all cell types of human body, including liver liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver, also includes liver. Cells are inside, so it can provide stable and sufficient sources of cells for the treatment of end liver disease. The transplanted hepatocytes can play a function replacement to support the repair of liver tissue, improve the coagulation function, and secrete multiple cytokines to promote liver cell proliferation. At the same time, the role of immune regulation is given to the restoration of the liver from multiple aspects.

Previous pre -clinical research has shown that liver cell preparations can significantly improve the survival rate of liver failure animals -compared with the survival rate of only 6.67% in the control group, the survival rate of the treatment group has increased significantly to 68.89%. At the same time, liver function The improvement of the coagulation function is improved, which plays the role of protecting the liver and promoting liver cell regeneration. The study is expected to be applied to clinical as soon as possible

According to reports, on April 13, 2022, the "Safety and Clinical Research Research on Human Embryo Stem Cells to induce and differentiated hepatocytes to treat acute/slow acute liver failure" project by Xiangya Hospital infection The official launch, this is also the first internationally the first clinical study of hepatochromic therapy for hepatocytes for the surrender of embryos.

Huang Yan introduced that the project has declared clinical research filing to the National Health and Health Commission in June 2019. After two years of repeated revision, clinical research registration has been completed. From May 2022, 10 patients are recruited for one year follow -up. Except for Mr. Chen, the second patient had been treated on July 18. At present, there are no adverse reactions. The symptoms of digestive tract are reduced. The coagulation function and liver function have improved significantly, and they are about to be discharged.

The hepatocyte preparations used in the project are derived from the National Engineering Research Center of Human Stem Cell. Professor Lin Ge, deputy director of the center, introduced that the hepatocyte preparations used in the project shall be produced in accordance with the requirements of the Quality Management of Drug Production (GMP). The product quality has been reviewed through the Chinese Food and Drug Inspection Research Institute. Complete the experiments such as preparation process, cell biological identification, and characteristic analysis, which can replace human liver cells.

At present, there are no embryo stem cell -related cell preparations around the world. The National Engineering Research Center of the Human Stem Cell will accelerate the processing process of the new drug declaration of hepatocytes derived from human embryonic stem cells. It is expected to be applied to the clinic as soon as possible to help patients with acute liver failure caused by various reasons.

[Responsible editor: Wang Yaobing Intern: Yang Shuwen]

[Source: Hunan Daily Xin]

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