Acute-On-Chronic Liver Failure Clinical Trial
Official title:
A Phase I Safety and Tolerability Dose Escalation Study of Micro-encapsulated Hepatocytes Intraperitoneal Transplantation Therapy for Adult Liver Failure Patients.
This is a prospective single-center dose escalation study of the administration of the microencapsulated hepatocyte therapy in adult liver failure. The purpose of the study is to determine the maximum tolerated dose of microencapsulated hepatocytes in liver failure patients and its effectiveness in treating the disease.
This study is a single-center unblinded single-arm study comprised of a dose escalation phase and a preliminary assessment of efficacy. Subjects who were diagnosed with liver failure (including chronic liver failure and acute-on-chronic liver failure) received 3 days' regular treatment with no beneficial effect and volunteered to participate in micro-encapsulated hepatocytes intraperitoneal transplantation therapy will be enrolled. Before the clinical research, the recruitment criteria and micro-encapsulated hepatocytes transplantation protocol will be confirmed. To minimize the number of patients receiving unbeneficial therapeutic dosage, the accelerated titration design and "3+3" design will be used to decide the dosage group. All micro-encapsulated hepatocytes transplantation patients will be monitored after 1, 3, 7, 14, 28, and 60 days after treatment for safety and primary efficacy analyses. The patients could still receive regular clinical treatment including liver transplantation. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05985863 -
Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT04822922 -
Safety of UC-MSC Transfusion for ACLF Patients
|
Phase 2 | |
| Recruiting |
NCT04578301 -
Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
|
||
| Completed |
NCT04983108 -
Utility of Liver and Splenic Stiffness in Predicting Esophageal Varices in Patients With Acute on Chronic Liver Failure
|
||
| Withdrawn |
NCT05940610 -
The Safety and Efficacy of MSC-EVs in Acute/Acute-on-Chronic Liver Failure
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05036031 -
Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study
|
||
| Recruiting |
NCT05019352 -
Cytokine Adsorption in Acute-on-chronic Liver Failure
|
N/A | |
| Recruiting |
NCT05421351 -
Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF
|
||
| Completed |
NCT02321371 -
Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.
|
N/A | |
| Not yet recruiting |
NCT06069037 -
SALT for Treatment of Patients With Early ACLF
|
N/A | |
| Completed |
NCT02965560 -
Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure
|
||
| Recruiting |
NCT03713489 -
Platelet Transfusion in HBV-related acute-on Chronic Liver Failure
|
N/A | |
| Withdrawn |
NCT03629015 -
Safety Study of Stemchymal® in Acute Liver Failure
|
Phase 1 | |
| Recruiting |
NCT04621812 -
Role of Fecal Microbiota in Predicting Graft Rejection and Sepsis Among Recipients of Living Donor Liver Transplant in First Year.
|
||
| Recruiting |
NCT04157465 -
Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients
|
N/A | |
| Suspended |
NCT03737448 -
TRimetazidine for acUte on Chronic Liver Failure STudy
|
Phase 1 | |
| Recruiting |
NCT06128421 -
Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk
|
N/A | |
| Recruiting |
NCT05700708 -
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
|
||
| Completed |
NCT04238416 -
Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF
|
Phase 1 | |
| Completed |
NCT03456518 -
Pattern of Acute on Chronic Liver Failure in Patient With HCV Related Chronic Liver Disease
|