Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis

March 17, 2021 updated by: RenJi Hospital

Clinical Study of Congener Allogeneic Hepatocyte Transplantation Treatment in Patients With Liver Cirrhosis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200127
        • Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Allogeneic Hepatocyte
Allogeneic hepatocyte with cell numbers L,M,H respectively.
Experimental: 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
Drug: Allogeneic Hepatocyte
Allogeneic hepatocyte with cell numbers L,M,H respectively.
Experimental: 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
Drug: Allogeneic Hepatocyte
Allogeneic hepatocyte with cell numbers L,M,H respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose
Time Frame: 28days
Observe the safety and tolerance after single infusion of hepatocyte.
28days
Dose-Limiting Toxicities
Time Frame: 28days
Observe the safety and tolerance after single infusion of hepatocyte.
28days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Qiang Xia, Doctor, Department of Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HI-IM-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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