Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis

Status Not yet recruiting

Clinical Trial Summary

The Primary Objective: To observe and determine the safety and tolerance of allogeneic hepatocyte transplantation in patients with liver cirrhosis and to establish the maximum-tolerated dose (MTD) and evaluate the dose-limiting toxicities (DLTs). The Secondary Objective: To observe the therapeutic efficacy of allogeneic hepatocyte transplantation for liver cirrhosis.

Clinical Trial 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 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04806581
Study type	Interventional
Source	RenJi Hospital
Contact	Qiang Xia, Doctor
Phone	0086-02168383134
Email	xiaqiang@medmail.com.cn
Status	Not yet recruiting
Phase	Phase 1
Start date	April 20, 2021
Completion date	March 31, 2025

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