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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Hepatocyte | Drug | Allogeneic hepatocyte with cell numbers L,M,H respectively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Xia, Doctor | Contact | 0086-02168383134 | xiaqiang@medmail.com.cn | |
| Yaoping Shi | Contact | 0086-02168383134 | shi_yaoping@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Xia, Doctor | Department of Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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Sequential Assignment
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| D013568 |
| Pathological Conditions, Signs and Symptoms |