A Clinical Research on the Safety of Hepatocytes Therapy Generated from Human Embryonic Stem Cells for Patients with Acute or Acute-on-Chronic Liver Failure

General Information

Clinical trials phase Other
Start date (estimated) 2022-01-01
End date (estimated) 2024-10-31
Clinical feature
Label Acute liver failure
Link http://www.orpha.net/ORDO/Orphanet_90062
Description A rare hepatic disease characterized by acute onset of severe liver dysfunction without evidence of underlying chronic liver disease. Patients present with nonspecific symptoms like jaundice, upper right abdominal pain, nausea, vomiting, pruritus, fatigue, and fever. The condition may rapidly progress to hepatic encephalopathy, coagulopathy, and life-threatening multiorgan failure. Liver biopsy typically shows massive hepatic necrosis.

Administrative Information

ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2100052988
Other study identifiers
Name ChiCTR2100052988
Description Chinese Clinical Trial Registry (ChiCTR)
Source weblink http://www.chictr.org.cn/showprojen.aspx?proj=133608
Public contact
Email 70950808@qq.com
Public email 70950808@qq.com
First name Sun
Last name Yi
Phone +86 731 88395675
City Changsha
Country
China
Address freetext 8 Luyun Road, Yuelu District, Changsha, Hunan, China
Sponsors Xiangya Hospital Central South University

Cells

Which differentiated cell type is used
Label hepatocyte
Link http://purl.obolibrary.org/obo/CL_0000182
Description The main structural component of the liver. They are specialized epithelial cells that are organized into interconnected plates called lobules. Majority of cell population of liver, polygonal in shape, arranged in plates or trabeculae between sinusoids; may have single nucleus or binucleated.; This extended description was generated by ChatGPT and reviewed by the CellGuide team, who added references, and by the CL editors, who approved it for inclusion in CL. It may contain information that applies to only to some subtypes and species, and so should not be considered definitional. Hepatocytes are the major cell type constituting 70-80% of the liver's cytoplasmic mass, playing crucial roles in maintaining the body's metabolic homeostasis. Dimensions of mature hepatocytes typically range from 20 to 30 μm in humans, but size may vary depending on their location within the liver lobule. Hepatocytes are characterized by high biosynthetic, enzymatic, and endocytic activity. They contain abundant mitochondria, smooth and rough endoplasmic reticulum, peroxisomes, lysosomes, and a large nucleus that is often binucleate. The liver consists of three zones - the periportal Zone 1, midzone 2, and pericentral Zone 3 - which have differential nutrient and oxygen status, and damage susceptibility; hepatocytes in the different zones show signifcant functional heterogeneity ('hepatocyte functional zonation'). Hepatocytes are involved in a multitude of critical functions including the metabolism of lipids, carbohydrates, and proteins, the synthesis of serum proteins (e.g., albumin, transferrin, and lipoproteins), the detoxification and excretion of endogenous and exogenous substances, the storage of vitamins and minerals, and the production and secretion of bile. Heterocytes demonstrate a remarkable regenerative capacity, which enables the liver to recover from injury and loss of tissue mass. Notably, hepatocytes perform biotransformation with both phase I and phase II enzymes, which modify drugs, xenobiotics, and various substances for elimination from the body. Phase I enzymes, such as cytochrome P450, catalyze both oxidative and reductive reactions of many xenobiotics; many of the products of phase I enzymes are substrates for the phase II enzymes, which catalyze conjugation reactions. Alterations in hepatocyte function have significant implications for overall human health and disease. Certain conditions, such as hepatitis, cirrhosis, and liver cancer, can profoundly affect hepatocyte structure and function, thereby disrupting the liver's ability to perform its vital roles within the body. As the primary site for drug metabolism, changes in hepatocyte function can also impact the effectiveness and toxicity of pharmaceuticals. The regenerative ability of hepatocytes makes them valuable cells for liver regenerative medicine and bioartificial liver support systems, and their study has provided significant insights into liver biology and disease.; Hepatocytes are reportedly MHC Class I-positive and MHC Class II-positive.

Recruitment

Recruitment Status Not yet recruiting
Estimated number of participants 10