Cirrhosis of Liver Due to Hepatitis B
Conditions
Interventions
Low-dose group:100mL with 2.5×10^7 human UC-MSCs was dripped into human subjects in day 1, day 8 and day 15. 3 times of therapy totally, interval time of 7 days.
Medium-dose group:100mL with 5.0×10^7 human UC-MSCs was dripped into human subjects in day 1, day 8 and day 15. 3 times of therapy totally, interval time of 7 days.
High low-dose group:100mL with 1.0×10^8 human UC-MSCs was dripped into human subjects in day 1, day 8 and day 15. 3 times of therapy totally, interval time of 7 days.
Sponsors
Zhongnan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, male or female. 2. A definite diagnosis of decompensated HBV-associated liver cirrhosis. 3. Poor effect of regular therapy; or relapse frequently. 4. Albumin in plasma 30%, Child –Pugh score>=7, MELD score 70g/L, platelet> 3x10^9/L. 6. Cannot receive live transplantation. 7. Patients who participate this clinical research voluntarily, and coordinate with doctors well. Also they should sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with complication of spontaneous peritonitis or other severe infection; 2. Patients with hepatorenal syndrome; 3. Suffered severe hepatic encephalopathy, massive alimentary tract bleeding or massive varicose bledding in last 1 month; 4. Patients with thrombosis in portal vein; or with complication of severe disease of heart, lung, kidney, blood system and endocrinology; 5. HIV positive; 6. Antibody of autoimmune liver diseases positive; 7. Patients who have malignant tumor in liver or other organs; 8. Female patients with pregnancy, in lactation period or who are plan to get pregnant recently; 9. Patients with insobriety, drug abused, also fail to quit it; 10. Patients who have participated in other clinical trials in last 3 months; 11. Patients who have participated in clinical trial of stem cells; 12. Patients was considered inappropriate to this trial by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The liver function (including ALB, ALT, AST, CHE, TBIL, DB, CHO, PTA, AT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival rate;The liver functionin (including ALB, ALT, AST, CHE, TBIL, DB, CHO, PTA, AT);The Child-Pugh score;The body weight of human subjects;The cirrhotic ascites;The clinic symptoms (Including lower limbs edema, hematemesis, jaundice, fatigue, poor appetite);The immunologic tests;The imageological examination;The quality of life (SF-36 scale);The MELD score; | — |
Countries
China
Contacts
Public ContactYufeng Yuan
Zhongnan Hospital
Outcome results
None listed