Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis

NCT04806581 | Unknown Phase 1

• 1 other identifier: HI-IM-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosis; allogeneic hepatocyte; transplantation

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose

  Observe the safety and tolerance after single infusion of hepatocyte.

  28days

• Dose-Limiting Toxicities

  Observe the safety and tolerance after single infusion of hepatocyte.

  28days

Study Arms (3)

Allogeneic Hepatocyte Cohort 1

EXPERIMENTAL

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 Cohort 2

EXPERIMENTAL

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 Cohort 3

EXPERIMENTAL

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

Interventions

Allogeneic Hepatocyte DRUG

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

Allogeneic Hepatocyte Cohort 1; Allogeneic Hepatocyte Cohort 2; Allogeneic Hepatocyte Cohort 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qiang Xia, Doctor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Xia, Doctor

CONTACT

0086-02168383134; xiaqiang@medmail.com.cn

Yaoping Shi

CONTACT

0086-02168383134; shi_yaoping@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: April 20, 2021
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)