Liver Failure, Acute on Chronic Clinical Trial
Official title:
Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | October 1, 2022 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Informed consent 2. Meeting the definition of ACLF: patients with previously diagnosed or undiagnosed chronic liver disease acute decompensated within 4 weeks; significant GI symptom as such fatigue, jaundice; serum total bilirubin [TBil] =10 X the upper limit of normal; coagulopathy (international normalized ratio [INR] =1.5 or prothrombin activity [PTA] <40%); complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination. 3. Model for End-Stage Liver Disease (MELD) scores ranging 17-30, (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643); 4. Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases 5. Body weight =50kg Exclusion Criteria: 1. Serious complications in the previous 2 months (e.g., gastrointestinal bleeding: hemoglobin below 90g/L, serious infection such as sepsis, ascites ultrafiltration, and/or dialysis); 2. Malignant jaundice induced by obstructive jaundice or hemolytic jaundice; 3. Hepatocellular carcinoma (HCC) diagnosed by radiologic imaging and/or alpha fetoprotein (AFP); 4. Tumor diagnosed by ultrasound, CT, MR examination; 5. Moderate or severe chronic heart failure (NYHA III-IV), renal replacement therapy, severe chronic pulmonary disease (GOLD III-IV) 6. Extrahepatic cholestasis 7. Hepatic, portal and splenic vein thrombosis diagnosed by doppler ultrasound 8. Artificial liver support 9. Previous liver transplantation 10. Drug abuse in the past 5 years; 11. Mental disorders and/or has a family history of mental disorder. 12. HIV infection 13. Pregnant or breast-feeding females 14. Highly allergic 15. Patients can not cooperate or mobility 16. Enrolled in other clinical trials with 3 months 17. Patients who can not provide prior informed consent or refusal to participate |
Country | Name | City | State |
---|---|---|---|
China | Tianjin Weikai Bioeng., Ltd. | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Weikai Bioeng., Ltd. | Tianjin Nankai Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | survival rate | Number of participants alive | 72 weeks after treatment | |
Secondary | Adverse reactions | Number of participants with adverse reactions (e.g. fever, rash, and diarrhea ) | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | White blood cell | Change of white blood cell count | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | Platelet | Change of platelet count | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | Hemoglobin | Change of hemoglobin level | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | Creatinine | Change of creatinine level as a surrogate marker of liver function | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | ALT | Change of alanine aminotransferase (ALT) level as a marker of liver function | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | ALB | Change of albumin (ALB) level as a maker of liver function | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | TBil | Change of total Bilirubin (TBil) level as a marker of liver function | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | INRs | Change of international normalized ratio (INRs) level as a marker of liver function | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | AFP | Change of alpha fetoprotein (AFP) level as a marker of liver function | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | MELD scores | Model for End-Stage Liver Disease (MELD) score for assessing the severity of chronic liver disease is measured as absolute change to baseline score | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | Tumor formation | Number of participants with hepatocellular carcinoma or extrahepatic malignant tumors | Week 1, 2, 4, 8, 12, 24, 36, 48 | |
Secondary | Liver failure-associated serious complications | Number of participants with liver failure-associated serious complications, such as infections, encephalopathy, gastrointestinal bleeding and HRS | Week 1, 2, 4, 8, 12, 24, 36, 48 |
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