Decompensated hepatitis B cirrhosis
Conditions
Interventions
Intervention group:UC-MSCs(umbilical cord mesenchymal stem cells) peripheral intravenous infusion (week 0, week 24)
Sponsors
Haikou People's Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 20-60 years (male or female); 2. Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years; 3. Not suitable for liver transplantation, or no source of donor liver; 4. No serious bleeding tendency or active bleeding; 5. No hepatic encephalopathy; 6. After strict medical conservative treatment for more than 6 months, there was no relief of symptoms or significant improvement of quality of life score; 7. The subject voluntarily participate in this study and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Family history of liver malignancy or patients with liver malignancy; 2. Patients with hypersplenism who need splenectomy; 3. Tumor history in other organ; 4. PT extension over 3 seconds; 5. Use of human serum albumin within 3 weeks prior to clinical enrollment; 6. Major upper gastrointestinal bleeding events of clinical significance occurred within 4 weeks prior to clinical registration; 7. Spontaneous peritonitis; 8. Active infection (viral or bacterial); 9. Pregnant or lactating women; 10. The investigator consider it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Child-Pugh Score;MELD(model for end-stage liver disease) score;FibroScan;Total bilirubin, albumin;HA, PIIINP, CIV, LN;CD4+ and CD8+T cell, NK cell;IgA, IgG, IgM, IgE;AFP, AFP-L3, CEA, CA19-9, CA15-3, PIVKA II;HBV-DNA;ECOG(Eastern Cooperative Oncology Group) score; | — |
Countries
China
Contacts
Public ContactHuang Xiaoxi
Haikou People's Hospital
Outcome results
None listed