Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Liver Cirrhosis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of participants (3 or 3+3 participants /cohort) will start on a fixed cell numbers of allogeneic hepatocyte in three cohorts separately: L dose (low cell numbers); M dose (medium cell numbers); H dose (high cell numbe...
A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of participants (3 or 3+3 participants /cohort) will start on a fixed cell numbers of allogeneic hepatocyte in three cohorts separately: L dose (low cell numbers); M dose (medium cell numbers); H dose (high cell numbers). The 1st cohort will be given dose of L. The 2nd cohort will be given dose of M. The 3rd cohort will be given dose of H. Dose escalation will continue until the maximum-tolerated dose (MTD). If no DLTs are observed for 28days after administration of the last dose, a new cohort will be enrolled at the next planned dose level. If DLTs are observed in 2 of the three participants, the MTD will be determined to be the dose administered to the previous cohort. If DLTs are observed in one participant in the cohort, another three participants will be treated with the same dose level. If the new three participants aren't observed DLTs, another cohort will be enrolled at the upper dose. If at least one of the new three ones are observed DLTs, the below dose will be the MTD. MTD will stopped by testing increasing up to the H dose. Toxicities will be graded using the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0).
Tracking Information
- NCT #
- NCT04806581
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Qiang Xia, Doctor Department of Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University
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