Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis

NCT ID: NCT04806581

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2025-03-31

Brief 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.

Detailed 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).

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Allogeneic Hepatocyte Cohort 1

Participants will each be administered L dose for one time. With 28days follow-up after the cells infusion.

Allogeneic hepatocyte cell numbers: L

Group Type: EXPERIMENTAL

Allogeneic Hepatocyte

Intervention Type: DRUG

Allogeneic hepatocyte with cell numbers L,M,H respectively.

Allogeneic Hepatocyte Cohort 2

Participants will each be administered M dose for one time. With 28days follow-up after the cells infusion.

Allogeneic hepatocyte cell numbers: M

Group Type: EXPERIMENTAL

Allogeneic Hepatocyte

Intervention Type: DRUG

Allogeneic hepatocyte with cell numbers L,M,H respectively.

Allogeneic Hepatocyte Cohort 3

Participants will each be administered H dose for one time. With 28days follow-up after the cells infusion.

Allogeneic hepatocyte cell numbers: H

Group Type: EXPERIMENTAL

Allogeneic Hepatocyte

Intervention Type: DRUG

Allogeneic hepatocyte with cell numbers L,M,H respectively.

Interventions

Allogeneic Hepatocyte

Allogeneic hepatocyte with cell numbers L,M,H respectively.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The age at the time of signing the informed consent from 18 to 70 years old (including the boundary value), both male and female;
• Clinical diagnosis of liver cirrhosis;
• Be able to understand and sign informed consent.

Exclusion Criteria

• Combined with liver cancer or other malignant tumors;
• Patients who can't cooperate;
• Prothrombin time (PT) exceeded the upper limit of normal control for 3-5 seconds or more;
• International normalized ratio (INR) >1.5;
• PLT<60×109/L；
• Recently use of anticoagulant or antiplatelet drugs (last 7 days);
• Recently (last 4 weeks) had upper gastrointestinal bleeding or spontaneous celiac inflammation;
• Moderate or large amount of ascites;
• The investigator assesses that the patient is unable or unwilling to comply with the protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Xia, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University

Locations

Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, , China

Countries

China

Central Contacts

Qiang Xia, Doctor

Role: CONTACT

xiaqiang@medmail.com.cn

0086-02168383134

Yaoping Shi

Role: CONTACT

shi_yaoping@163.com

0086-02168383134

Other Identifiers

HI-IM-001

Identifier Type: -

Identifier Source: org_study_id