10
Participants
Start Date
March 1, 2024
Primary Completion Date
December 31, 2025
Study Completion Date
February 28, 2026
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."
RECRUITING
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai Institute of Biochemistry and Cell Biology
UNKNOWN
RenJi Hospital
OTHER