Clinical Study of Congener Allogeneic Hepatocyte Transplantation Treatment in Patients With Liver Cirrhosis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
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.
详细描述
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Allogeneic Hepatocyte Cohort 1
Participants will each be administered L dose for one time. With 28days follow-up after the cells infusion.
Allogeneic hepatocyte cell numbers: L
干预措施: Allogeneic Hepatocyte (Drug)
Allogeneic Hepatocyte Cohort 2
Participants will each be administered M dose for one time. With 28days follow-up after the cells infusion.
Allogeneic hepatocyte cell numbers: M
干预措施: Allogeneic Hepatocyte (Drug)
Allogeneic Hepatocyte Cohort 3
Participants will each be administered H dose for one time. With 28days follow-up after the cells infusion.
Allogeneic hepatocyte cell numbers: H
干预措施: Allogeneic Hepatocyte (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 28days
Observe the safety and tolerance after single infusion of hepatocyte.
Dose-Limiting Toxicities
时间窗: 28days
Observe the safety and tolerance after single infusion of hepatocyte.
次要结局
未报告次要终点