Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis
NCT04806581 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2021-03-19
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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