Phase I (Single Administration, Randomized, Double-blind, Dose Escalation)Primary Objective: To evaluate the safety and tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis, and to determine the safe clinical dose.Secondary Objective: To evaluate the preliminary efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis, providing a basis for the design of subsequent clinical trial protocols.Exploratory Objective: To evaluate the pharmacokinetic characteristics and immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Phase II (Multiple Administrations, Randomized, Double-blind, Dose Expansion)Primary Objective: To evaluate the preliminary efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Secondary Objective: To evaluate the safety of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Exploratory Objective: To evaluate the pharmacokinetic characteristics and immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
venous reinfusion
Zhongnan Hospital of Wuhan University
Wuhan, China
RECRUITINGIncidence and characteristics of any adverse events and serious adverse events associated with human umbilical cord mesenchymal stem cell injection therapy
Safety Indicator
Time frame: within 28 days after administration
Determine the recommended dose for phase II(RP2D)
Safety Indicator
Time frame: Periprocedural
Change of Model for End-stage Liver Disease score from baseline
The calculated baseline score is 6 points. The 40-point mark is an upper limit set in clinical application, used to indicate an extremely high risk of mortality and to guide the most urgent allocation of liver transplants. Efficacy Endpoint
Time frame: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Child-Pugh score change from baseline
The theoretical minimum score of the Child-Pugh classification is 5 points, and the maximum is 15 points. A higher score indicates poorer liver reserve function and a less optimistic prognosis for the patient Efficacy Endpoint
Time frame: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Hepatic hardness changes from baseline
Efficacy Endpoint
Time frame: Week 24, week 52 after administration
Spleen hardness changes from baseline
Efficacy Endpoint
Time frame: Week 24, week 52 after administration
Change in Liver Function Indicators from Baseline: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), Gamma-Glutamyl Transferase (γ-GGT), Alkaline Phosphatase (ALP), Albumin (ALB), Cholinesterase (CHE)
Efficacy Endpoint
Time frame: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Change in International Normalized Ratio from Baseline
Efficacy Endpoint
Time frame: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Prothrombin Time from Baseline
Efficacy Endpoint
Time frame: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Prothrombin Activity from Baseline
Efficacy Endpoint
Time frame: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Change in HBV DNA from Baseline
Efficacy Endpoint
Time frame: Week 1, week 2, week 8, week 24, week 36, week 52 after administration
Liver transplant-free survival
Efficacy Endpoint
Time frame: Periprocedural
The incidence of complications related to decompensated cirrhosis (the following complications were calculated separately: esophageal and gastric varices bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome)
Efficacy Endpoint and Safety Indicator
Time frame: Periprocedural
Incidence and Characteristics of Any Treatment-Related Adverse Events and Serious Adverse Events Associated with Human Umbilical Cord Mesenchymal Stem Cell Injection Therapy
Safety Indicator
Time frame: Week 5 to week 52 after administration
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