This clinical trial is a Phase 1, multiple administration, dose-escalasion clinical trial of human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis. The primary objective of this study is to assess the safety of intravenous infusion of human umbilical cord-derived mesenchymal stem cells in patients with decompensated cirrhosis.
Decompensated cirrhosis has a high overall mortality rate. There is unmet need for safe and alternative therapeutic potions. This clinical trial is a Phase 1, multiple administration, dose-escalasion clinical trial of human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis. The primary objective of this study is to assess the safety of intravenous infusion of human umbilical cord-derived mesenchymal stem cells in patients with decompensated cirrhosis.In order to illustrate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells and the patient's dose tolerance to human umbilical cord-derived mesenchymal stem cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Human Umbilical Cord-derived Mesenchymal Stem Cells will be administered intravenously.
Beijing 302 Hospital
Beijing, China
Incidence of Adverse Events
Time frame: from baseline to 28th day
incidence of dose-limiting toxicity-related adverse events
Time frame: from baseline to 28th day
maximum tolerated dose
Time frame: from baseline to 28th day
Change in Model for End-Stage Liver Disease (MELD) score from baseline to 28th day
The Model for End-stage Liver Disease (MELD) is a scoring system that evaluates the liver function reserve and prognosis of patients with chronic liver disease by creatinine, international normalized ratio (INR), and bilirubin-conjugated cirrhosis etiology. The MELD score is calculated by the formula: R = 9.6 × ln (creatinine mg/dl) + 3.8 × ln (bilirubin mg/dl) + 11.2 × ln (INR) + 6.4 × etiology, and the results are taken as integers. ( 0 for cholestatic and alcoholic cirrhosis and 1 for other causes of cirrhosis such as viruses).
Time frame: at 28th day
Change in Model for End-Stage Liver Disease (MELD) score from baseline to 3 days, 7days, 14 days, 21 days, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, and 24 months
Time frame: 3 days, 7days, 14 days, 21 days, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, and 24 months
Incidence of each complication associated with decompensated cirrhosis
Time frame: up to 24 months
liver transplant-free survival
Time frame: up to 24 months
Incidence of liver failure
Time frame: up to 24 months
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plasma albumin (ALB)
Time frame: up to 24 months
plasma prealbumin (PALB)
Time frame: up to 24 months
total bilirubin (TBIL)
Time frame: up to 24 months
serum cholinesterase (CHE)
Time frame: up to 24 months
prothrombin time (PT)
Prothrombin time (PT) is a blood test that measures the time it takes for plasma to clot, to check for bleeding problems, or to check whether medicine to prevent blood clots is working.
Time frame: up to 24 months
Child-Turcotte-Pugh (CTP) score
Child-Turcotte-Pugh (CTP) score is a scoring system that evaluates the liver function. Maximum is 15, minimum is 5. Higher scores mean a worse outcome.
Time frame: up to 24 months
EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D)
Quality of life assessment. Maximum is 5, minimum is 1. Lower scores mean a better outcome.
Time frame: up to 24 months
Incidence of liver cancer
Time frame: up to 24 months
ChronicLiver Disease Questionnaire (CLDQ)
Quality of life assessment. The Chronic Liver Disease Questionnaire (CLDQ) was developed as an evaluative instrument to measure longitudinal change in health status within individuals with chronic liver disease. In addition to measuring both physical and mental health, the instrument was designed to be a disease-specific tool for assessing areas of function important to patients with chronic liver disease. Maximum is 7, minimum is 1. Higher scores mean a better outcome.
Time frame: up to 24 months