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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20250073 | Other Grant/Funding Number | National Medical Products Administration |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Umbilical Cord Mesenchymal Stem Cells Injection 5 × 10^7 cells per person per administration | Experimental | Duration of administration: single dose |
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| Human Umbilical Cord Mesenchymal Stem Cells Injection 1×10^8cells per person per administration | Experimental | Duration of administration: single dose |
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| Human Umbilical Cord Mesenchymal Stem Cells 2×10^8cells per person per administration | Experimental | Duration of administration: single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Umbilical Cord Mesenchymal Stem Cells Injection | Biological | venous reinfusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and characteristics of any adverse events and serious adverse events associated with human umbilical cord mesenchymal stem cell injection therapy | Safety Indicator | within 28 days after administration |
| Determine the recommended dose for phase II(RP2D) | Safety Indicator | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi Cheng | Contact | +8618504341228 | thswcs@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | China |
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| 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 | 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 | Week 24, week 52 after administration |
| Spleen hardness changes from baseline | Efficacy Endpoint | 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 | 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 | Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration |
| Prothrombin Time from Baseline | Efficacy Endpoint | Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration |
| Prothrombin Activity from Baseline | Efficacy Endpoint | 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 | Week 1, week 2, week 8, week 24, week 36, week 52 after administration |
| Liver transplant-free survival | Efficacy Endpoint | 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 | 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 | Week 5 to week 52 after administration |