Liver Cirrhosis
Conditions
Keywords
Liver cirrhosis; allogeneic hepatocyte; transplantation
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.
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).
Interventions
DRUGAllogeneic Hepatocyte
Allogeneic hepatocyte with cell numbers L,M,H respectively.
Sponsors
RenJi Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sequential Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose | 28days | Observe the safety and tolerance after single infusion of hepatocyte. |
| Dose-Limiting Toxicities | 28days | Observe the safety and tolerance after single infusion of hepatocyte. |
Countries
China
Contacts
Primary ContactQiang Xia, Doctor
Backup ContactYaoping Shi
Outcome results
None listed