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Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.
To investigate safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B virus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treatment | Experimental | Participants will receive conventional treatment and then be followed until the week 48 study visit. |
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| Conventional plus UC-MSC treatment | Experimental | Participants will receive conventional treatment plus a dose of UC-MSC and then be followed until the week 48 study visit. |
|
| Conventional plus PE treatment | Experimental | Participants will receive conventional treatment plus plasma exchange and then be followed until the week 48 study visit. |
|
| Conventional plus UC-MSC and PE therapy | Experimental | Participants will receive conventional treatment plus umbilical cord mesenchymal stem cells transplantation combined with plasma exchange. Participants will then be followed until the week 48 study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional plus UC-MSC treatment | Other | Received conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times). |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate and time | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on] | 24 weeks after treatment | |
| The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi-Liang Gao, Professor | Contact | 86-20-85252373 | zhilianggao@21cn.com | |
| Hong-Liang He, Master | Contact | 86-20-85253372 | hehongliang0925@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhi-Liang Gao, Doctor | The Third Affliated Hospital of Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30863450 | Derived | Xu WX, He HL, Pan SW, Chen YL, Zhang ML, Zhu S, Gao ZL, Peng L, Li JG. Combination Treatments of Plasma Exchange and Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation for Patients with Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Clinical Trial in China. Stem Cells Int. 2019 Feb 4;2019:4130757. doi: 10.1155/2019/4130757. eCollection 2019. |
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| Conventional plus PE treatment | Other | Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). |
|
| Conventional plus UC-MSC and PE therapy | Other | Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). Meantime taken i.v umbilical cord mesenchymal stem cells transplantation slowly for 30minutes (1×105/Kg, once a week, 4 times), the first two times is taken after plasma exchange. |
|
| Conventional treatment | Other | Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine. |
|
| 24 weeks after treatment |
| Liver function evaluation using Child-Pugh score and MELD score | 24 weeks after treatment |
| Immune function improvement [including Th1/Th2] | 24 weeks after treatment |
| The occurrence of complications [including body temperature, tetter and allergy] | Between 0 to 8 hours after UC-MSCs transfusion |
| Incidence of hepatocellular carcinoma | 48 weeks after treatment |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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