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Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04806581
Recruitment Status : Not yet recruiting
First Posted : March 19, 2021
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Drug: Allogeneic Hepatocyte Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Congener Allogeneic Hepatocyte Transplantation Treatment in Patients With Liver Cirrhosis
Estimated Study Start Date : April 20, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 28days ]
    Observe the safety and tolerance after single infusion of hepatocyte.

  2. Dose-Limiting Toxicities [ Time Frame: 28days ]
    Observe the safety and tolerance after single infusion of hepatocyte.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806581


Contacts
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Contact: Qiang Xia, Doctor 0086-02168383134 xiaqiang@medmail.com.cn
Contact: Yaoping Shi 0086-02168383134 shi_yaoping@163.com

Locations
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China
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China, 200127
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: Qiang Xia, Doctor Department of Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University
More Information
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04806581    
Other Study ID Numbers: HI-IM-001
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
Liver cirrhosis; allogeneic hepatocyte; transplantation
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases