Chronic hepatitis B
Conditions
Interventions
Antiviral drugs treatment group:IFNa+NA plan
Autologous cell source group:Treatment with of specific TCL cells from autologous patients
Umbilical cord blood cell source group:Treatment with of specific TCL cells from umbilical cord blood
Sponsors
Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Males or females aged from 18 to 65 years old; 2. Chronic HBV infected patients based on diagnostic criteria of 2010 China clinical practice guidelines of chronic hepatitis B (updated); 3. positive HBsAg, positive HBeAg and serum HBV DNA level >=2000IU/ml; 4. The value of ALT level>2xULN; 5. Poor curative effect for anti-virus treatment or immunomodulator taken within 6 months before inclusion; 6. Histological proved hepatic necrotizing inflammation with destruction or fibrosis METAVIR Score> Grade 2 or F2 phase; 7. To be able to understand and sign the informed consent; 8. Good medical compliance.
Exclusion criteria
Exclusion criteria: 1. Positive anti-HCV, positive anti-HDV IgM or positive anti-HIV; 2. ANA titer >1:160; 3. Decompensated liver diseases (rupture of esophageal and gastric varices, hepatic encephalopathy); 4. Existing diseases as bellows: myocardial infarction, Congestive heart failure, severe hypertension, malignant tumor diseases, mental diseases , Autoimmune liver disease,Severe fatty liver and alcoholism; 5. Anaphylaxis; 6. Pregnant subject or in lactation; 7. History of organ transplantation; 8. Subject involved in any other clinical trial in recent 3 months; 9. Any factor not appropriate for subject to be involved into or to finish this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg;HBeAg;HBV-DNA;Serum ALT;hepatic pathology; | — |
Countries
China
Contacts
Public ContactZhao Zhenlin
Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine
Outcome results
None listed