Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells for Treating Decompensated Liver Cirrhosis Associated With HBV
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- HBV
- Sponsor
- Zhongnan Hospital
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- cholinesterase in U/L
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study was to observe the safety ,tolerability ,Efficacy dose of human umbilical cord mesenchymal stem cells in patients of decompensated liver cirrhosis with HBV.
Detailed Description
Investigators plan to recruit 24 voluntary patients of decompensate liver cirrhosis with HBV, dividing them into 3 group：1) low-dose group: 100mL with 2.5×10\^7 cells；2) medium-dose group: 100mL with 5.0×10\^7 cells；3) high-dose group: 100mL with 1.0×10\^8 cells. Each group contains 8 patients. Investigators treat the participants with human umbilical cord mesenchymal stem cells via venous transfusion. First investigators arrange a whole test for participants, such as vital sign examination, laboratory test, ECG, CT, MRI, ultrasound etc. Investigators screen these patients with a complete eligibility criteria. Then investigators proceed the therapy in the 1st, 8th and 15th day. There are 8 times of follow-up visit for these patients, 4 times of those are proceeded during the hospitalization, while other 4 times happens after the discharge. The follow-up visit includes vital sign examination, laboratory test, ECG, CT, MRI, ultrasound, Child-Pugh grade, MELD grade, SF-36 test. These follow-up visit last 24 weeks since the first treatment. After that, investigators also arrange a survival visit through phone or clinic each 6 months, lasting another 1.5 years. The main object of this research is investigating the survival rate, promotion of the liver function, improvement of health, safety of hUC-MSCs, tolerability of patients, for exploring a new way for the therapy of decompensated liver cirrhosis with HBV.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged between 18 and 65 (including 18 and 65), regardless of gender;
- •Decompensated stage of viral hepatitis B cirrhosis;
- •The effect of conventional medical treatment is not good, and the condition is repeated;
- •ALB \< 35g/L, TBIL \< 170μmol/L, INR \> 30%, Child-pugh score ≥7; MELD score ≤15;
- •Hgb \> 70g/L, PLT \> 3×109/L;
- •Unconditional acceptance for liver transplantation; 7）Participate in the clinical study voluntarily, cooperate with doctors to carry out the study, and sign informed consent.
Exclusion Criteria
- •With spontaneous peritonitis or other serious infection;
- •Patients with hepatorenal syndrome;
- •Severe hepatic encephalopathy, massive hemorrhage of digestive tract or varicose
- •vein in recent 1 month;
- •Portal vein thrombosis; Complicated with serious diseases of heart, lung, kidney,
- •blood and endocrine system;
- •HIV positive;
- •Positive autoantibodies related to autoimmune liver disease;
- •Presence of liver or any type of malignant tumor;
- •Pregnant women, breast-feeding women or those with recent birth plans;
Outcomes
Primary Outcomes
cholinesterase in U/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Antithrombin in mg/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Serum albumin in g/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
aspartate aminotransferase in U/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Serum cholesterol in mmol/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Prothrombin activity in percentage
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
alanine aminotransferase in U/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Total bilirubin in μmol/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Direct bilirubin in μmol/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Secondary Outcomes
- Child-Pugh grade(24 weeks)
- Interleukin-1β cells in pg/mL(24 weeks)
- The Medical outcomes study 36-item Short Form Health Survay scale (SF-36 scale)(24 weeks)
- Natural killer T cells in percentage(24 weeks)
- survival rate(2 years)
- Ascites(24 weeks)
- Th1 cells in percentage(24 weeks)
- Th2 cells in percentage(24 weeks)
- Interleukin-6 cells in pg/mL(24 weeks)
- Interleukin-4 cells in pg/mL(24 weeks)
- Interleukin-17A cells in pg/mL(24 weeks)
- Medical images(24 weeks)
- Interleukin-12 cells in pg/mL(24 weeks)
- Interleukin-15 cells in pg/mL(24 weeks)
- Rate of weight change(24 weeks)
- clinical symptoms(24 weeks)
- Interleukin-8 cells in pg/mL(24 weeks)
- MELD score(24 weeks)