hepatitis B cirrhosis (compensatory stage)
Conditions
Interventions
Control:Tenofovir + anluo chemical fiber pills + placebo
Treatment group:Tenofovir + anluo chemical fiber pill + umbilical cord mesenchymal stem cells
Sponsors
People's Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) The applicant aged between 18 and 65 years; (2) There was evidence of liver cell synthesis dysfunction or portal hypertension by transient elastography, imaging and laboratory examination, or cirrhosis was diagnosed histologically, but no symptoms or serious complications such as esophageal and gastric varices rupture and bleeding, ascites or hepatic encephalopathy, etc.; (3) Plasma albumin >=35g/L, total bilirubin 60%, Child-Pugh score A; (4) Volunteer to participate in the clinical study, cooperate with doctors to carry out the study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Complicated with spontaneous peritonitis or other serious infection; (2) Patients with hepatorenal syndrome; (3) severe hepatic encephalopathy, massive gastrointestinal bleeding or varicose venous bleeding; (4) Complicated with serious diseases of heart, lung, kidney, blood and endocrine system; Portal vein thrombosis; (5) Serum HIV antibody positive patients; (6) The etiology of cirrhosis is non-chronic HBV infection (HCV, EBV, CMC, autoimmune liver disease, primary biliary cirrhosis, parasitic, alcoholic, drug-related, genetic metabolic, genetic metabolic disease), or there are other factors besides chronic HBV infection; (7) Malignant tumors of the liver or other organs; (8) Pregnant women, lactating women or recent family planning; (9) People who have a history of alcohol and drug abuse and have failed to quit effectively; (10) Participated in other clinical trials within 3 months before enrollment; (11) Participated in stem cell clinical research; (12) Unwilling to sign the informed consent; (13) Concomitant with neurological or mental disorders and unable to cooperate or unwilling to cooperate; (14) Other conditions considered by the investigator to be inappropriate for the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver hardness number;Serum hepatic fibrosis indicators (IV-C, HA, LN and PC-III);Liver biopsy pathology, electron microscopic pathology, cellular immunity, humoral immunity before and 36 weeks after stem cell intervention.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function index;B-ultrasound;Two half-and-half HBV;HBV-DNA; | — |
Countries
China
Contacts
Public ContactJiang Ying'an
People's Hospital of Wuhan University
Outcome results
None listed