Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis

NCT04806581 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-03-19

No results posted yet for this study

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

Interventions

DRUG

Allogeneic Hepatocyte

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

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04806581 on ClinicalTrials.gov