At a glance
ClinicalIndex Comparison Record- ✓Body weight greater than 40 kg
- ✓Age 18 to 65 years old
- ✓CLF group: progressive liver function decline or decompensation after liver cirrhosis
- ✓CLF group: serum total bilirubin higher than normal but less than 10 times ULN
- ✕Brain edema, cerebral hernia, or intracranial hemorrhage
- ✕Diagnosed or suspected primary or metastatic liver cancer
- ✕Uncorrectable oxygenation index (PaO2/FiO2) <200
- ✕Disseminated intravascular coagulation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05727722Phase 1RecruitingUpdate OverdueUpdated 12mo ago · Completion was 6mo agoA Phase I Safety and Tolerability Dose Escalation Study of Micro-encapsulated Hepatocytes Intraperitoneal Transplantation Therapy for Adult Liver Failure Patients.
In Brief
A Phase 1 clinical trial evaluating a single course of micro-encapsulated hepatocytes intraperitoneal transplantation therapy for Acute-On-Chronic Liver Failure and Chronic Liver Failure. Currently recruiting, targeting 10 participants across 1 site.
Signals
Detailed Summary
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. We previously generated proliferating human hepatocytes (ProliHH) through dedifferentiation of PHH and engineered them into encapsulated liver organoids (eLO), providing an unlimited cell source for hepatocyte transplantation.
Study Details
Timeline
Interventions
A single course will be divided into an "accelerated titration design" phase and a "3+3 design" phase to reduce the number of subjects exposed to potentially ineffective doses that may not benefit from treatment. The "accelerated titration design" phase starts at a starting dose of 0.15x10\^9, moving to the "3+3 design" phase at the dose of 0.5x10\^9. According to the semi-logarithmic incremental (10\^0.5-fold) approach, the treatment dosage was set into four groups at a maximum dose of 4.5×10\^9 (allowing for a ±20% difference between the actual dose and the planned dose, considering production specifics). The number or the incremental ratio of subsequent dose groups can be adjusted based on the evaluation of available data in the study, and intermediate doses can be explored.