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RECRUITINGPhase 1INTERVENTIONAL

hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis. 2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat. 3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2, including boundary value; - The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score≤21 points. - Have not received stem cell therapy in the recent 6 months; - Subjects will be able to sign the willing to sign a consent form in accordance with the study procedures and instructions. Who Should NOT Join This Trial: - Insufficiency of vital organs, such as heart, kidney and lung; - End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc. - Concomitant peritonitis, pneumonia, or other types of infection not under control; - Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine; - Positive serum HIV antibody and syphilis antibody; - Alpha fetoprotein\>400ng/mL with primary liver cancer or without imaging evidence; - Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ; - Patients with severe mental illness and cognitive impairment; Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2, including boundary value; * The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score≤21 points. * Have not received stem cell therapy in the recent 6 months; * Subjects will be able to sign the informed consent in accordance with the study procedures and instructions. Exclusion Criteria: * Insufficiency of vital organs, such as heart, kidney and lung; * End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc. * Concomitant peritonitis, pneumonia, or other types of infection not under control; * Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine; * Positive serum HIV antibody and syphilis antibody; * Alpha fetoprotein\>400ng/mL with primary liver cancer or without imaging evidence; * Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ; * Patients with severe mental illness and cognitive impairment;

Treatments Being Tested

BIOLOGICAL

Peripheral iv

6\*10\^7 cells

Locations (1)

Xiangya Hospital Central South University
Changsha, Hunan, China