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| ID | Type | Description | Link |
|---|---|---|---|
| LBingliang | Registry Identifier | Bing-liang Lin |
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Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24 weeks survival rate of ACLF patients. In this study, we intend to assess the safety and efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group MSC-1 | Experimental | Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 8 weeks. |
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| Group MSC-2 | Experimental | Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 4 weeks. |
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| Group Control | No Intervention | Patients in Group Control received standard medical treatment, including bed rest, nutritional supplementation, administration of human serum albumin (10g per day until serum albumin was 35g/L) and plasma (200 ml to 400 ml per day until the international normalized ratio was less than 1.5), anti-viral therapy, glycyrrhizin,S-adenosylmethionine and appropriate treatment for complications (such as infection, encephalopathy, hepatorenal syndrome and intestinal paralysis). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord blood mesenchymal stem cells | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions. | 52 weeks | |
| The survival time of patients after UC-MSC infusions. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The influence on levels of ALT (U/L) and AST (U/L) after UC-MSC infusions | 1,2,3,4,8,12,24,36,52weeks | |
| The influence on levels of ALB(g/L) after UC-MSC infusions | 1,2,3,4,8,12,24,36,52weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| The influence on levels of TBil (umol/L) after UC-MSC infusions |
| 1,2,3,4,8,12,24,36,52weeks |
| The influence on levels of INR after UC-MSC infusions | 1,2,3,4,8,12,24,36,52weeks |
| The influence on levels of MELD score, SOFA score and CTP score after UC-MSC infusions | 1,2,3,4,8,12,24,36,52weeks |
| The incidence of fatal complications after UC-MSC infusions. | 52 weeks |
| Comparison of levels of NKG2A among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of NKG2D among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of NKP46 among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of perforin among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of FasL among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of gramzymeB among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |