Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults

PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

February 28, 2026

Conditions
Acute-On-Chronic Liver FailureChronic Liver Failure
Interventions
BIOLOGICAL

a single course of micro-encapsulated hepatocytes intraperitoneal transplantation therapy

"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."

Trial Locations (1)

Unknown

RECRUITING

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
collaborator

Shanghai Institute of Biochemistry and Cell Biology

UNKNOWN

lead

RenJi Hospital

OTHER