Status:
UNKNOWN
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Lead Sponsor:
Tianjin Weikai Bioeng., Ltd.
Collaborating Sponsors:
Tianjin Nankai Hospital
Conditions:
Liver Failure, Acute on Chronic
Eligibility:
All Genders
16-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Detailed Description
Acute-on-chronic liver failure (ACLF) which occurs in patients with chronic liver disease, is a serious live-threatening disease. Currently, the clinical management, such as liver protection, anti-vir...
Eligibility Criteria
Inclusion
- Informed consent
- 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.
- 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);
- Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
- Body weight ≥50kg
Exclusion
- 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);
- Malignant jaundice induced by obstructive jaundice or hemolytic jaundice;
- Hepatocellular carcinoma (HCC) diagnosed by radiologic imaging and/or alpha fetoprotein (AFP);
- Tumor diagnosed by ultrasound, CT, MR examination;
- Moderate or severe chronic heart failure (NYHA III-IV), renal replacement therapy, severe chronic pulmonary disease (GOLD III-IV)
- Extrahepatic cholestasis
- Hepatic, portal and splenic vein thrombosis diagnosed by doppler ultrasound
- Artificial liver support
- Previous liver transplantation
- Drug abuse in the past 5 years;
- Mental disorders and/or has a family history of mental disorder.
- HIV infection
- Pregnant or breast-feeding females
- Highly allergic
- Patients can not cooperate or mobility
- Enrolled in other clinical trials with 3 months
- Patients who can not provide prior informed consent or refusal to participate
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03863002
Start Date
October 1 2019
End Date
October 1 2022
Last Update
March 20 2019
Active Locations (1)
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1
Tianjin Weikai Bioeng., Ltd.
Tianjin, Tianjin Municipality, China