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HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treatment | Experimental | Participants will receive conventional treatment and then be followed until the week 72 study visit. |
|
| Conventional plus BM-MSC treatment | Experimental | Participants will receive conventional treatment plus a dose of BM-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit. |
|
| Conventional plus UC-MSC treatment | Experimental | Participants will receive conventional treatment plus a dose of UC-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional plus BM-MSC treatment | Genetic | Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times). |
| Measure | Description | Time Frame |
|---|---|---|
| survival rate | The survival rate and time | 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function | The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST),Cholinesterase (CHE) ,Total Bilirubin(TB),Direct Bilirubin(DB), Serum Albumin （ALB） | 72 weeks after treatment |
| Marker of liver cancer |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qihuan Xu, Doctor | Contact | +86 20 85253179 | xqh0303@yahoo.com | |
| Qi Zhang, Doctor | Contact | +86 20 85253106 | kee_kee@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qi Zhang, Doctor | Third Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qi Zhang | Recruiting | Guangzhou | Guangdong | 510630 | China |
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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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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| D000998 | Antiviral Agents |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
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| Conventional plus UC-MSC treatment | Genetic | Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times) |
|
| Conventional treatment | Drug | Received conventional treatment including: A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al); B.Hepatoprotective drugs(Ademetionine1,4-butanethiosulfonate for Injection, Reduced Glutathione for Injection,Polyene Phosphatidylcholine, et al); C.Plasma. |
|
|
The level of alpha-fetoprotein (AFP)
| 72 weeks after treatment |
| The degree of hepatic necrosis | The levels of Prothrombin Activity (PA) and Prothrombin Time (PT) | 2 years after treatment |
| The improvement of symptoms | The improvement of clinical symptoms [including appetite, debilitation, abdominal distension, edema of lower limbs, et al](streamdown:incomplete-link) | 72 weeks after treatment |
| The score for Model for End-Stage Liver Disease | 72 weeks after treatment |
| The improvement of immune function | cluster of differentiation 4 (CD4+)T/ cluster of differentiation 8 (CD8+)T,T helper cell 1 (Th1)/ T helper cell 1(Th2),natural killer cell(NK),natural killer T(NK T),interleukin-1β(IL-1β),interleukin-4(IL-4),interleukin-6(IL-6),interleukin-8(IL-8),interleukin-12(IL-12),interleukin-15(IL-15),interleukin-17A(IL-17A),Tumor necrosis factor-alpha (TNF-α),Interferon-gamma (IFN-γ) | 72 weeks after treatment |
| complications | The occurrence of complications [including body temperature, tetter and allergy] | Between 0 to 8 hours after MSC transfusion |
| The incidence of hepatocellular carcinoma | 72 weeks after treatment |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |