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临床试验/NCT07312864
NCT07312864招募中1 期

A Clinical Trial Assessing the Safety, Tolerability, and Exploratory Efficacy of a Novel Bioartificial Liver Therapy in Patients With Liver Failure or Small-for-Size Syndrome

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年12月1日最近更新:
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适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
12
试验地点
1
主要终点
Number of participants with treatment-emergent adverse events and serious adverse events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical trial is to evaluate the safety and tolerability of a novel bioartificial liver (CiPS-BAL) in patients with liver failure or small-for-size syndrome. The study will also collect preliminary data on clinical outcomes and laboratory parameters during treatment. The main questions it aims to answer are:

Is the novel bioartificial liver system safe and well tolerated in patients with liver failure or small-for-size syndrome?

What effects does the treatment have on liver function and other clinical and laboratory indicators?

Researchers will treat participants with the CiPS-BAL system, which uses hepatocytes derived from chemically induced pluripotent stem cells (CiPS) within a bioartificial liver device.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with liver failure (including acute, subacute/acute-on-chronic, and chronic liver failure) or small-for-size syndrome

排除标准

  • •Presence of severe extrahepatic systemic end-stage diseases
  • •Uncontrollable infection or active bleeding
  • •Pregnant or breastfeeding women
  • •History of allergy or known severe hypersensitivity to CiPSC-derived cell products or blood products
  • •Peripheral vascular collapse leading to inability to obtain venous access or collect blood
  • •Unable or unwilling to provide informed consent or unable to comply with study requirements
  • •Unwilling to receive CiPSC-based therapy

研究组 & 干预措施

CiPS-BAL

Experimental

Chemically induced pluripotent stem cells biological Artificial Liver

干预措施: Chemically induced pluripotent stem cells biological Artificial Liver (Biological)

结局指标

主要结局

Number of participants with treatment-emergent adverse events and serious adverse events

时间窗: From completion of CiPS-BAL therapy through Week 4 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4).

The number and proportion of participants experiencing treatment-emergent adverse events (AEs) and serious adverse events (SAEs) following CiPS-BAL therapy, including but not limited to fever, rash, chest tightness, palpitations, acute infusion reactions, immune rejection, infections, and local complications (e.g., hematoma, bleeding), and thrombosis. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Survival and Liver Transplantation Rate

时间窗: From completion of CiPS-BAL therapy through Week 4 post-treatment (assessed at 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4,).

Overall survival of the patients and the proportion of participants who undergo liver transplantation during the study period.

Model for End-Stage Liver Disease (MELD) score/Pediatric End-Stage Liver Disease (PELD) score

时间窗: From completion of CiPS-BAL therapy through Week 4 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4)

Changes in MELD/PELD score over time will be used to evaluate disease severity and treatment response.

Number of participants with treatment-emergent adverse events and serious adverse events

时间窗: From initiation of CiPS-BAL therapy through 12 months post-treatment (assessed at Day 7, Week 4, Week 12, Month 6, and Month 12)

The number and proportion of participants experiencing treatment-emergent adverse events (AEs) and serious adverse events (SAEs) following CiPS-BAL therapy, including but not limited to fever, rash, chest tightness, palpitations, acute infusion reactions, immune rejection, infections, and local complications (e.g., hematoma, bleeding), and thrombosis. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Survival and Liver Transplantation Rate

时间窗: 7 days, 4 weeks, 12 weeks, 6 months, and 12 months after CiPS-BAL therapy.

Overall survival of the patients and the proportion of participants who undergo liver transplantation during the study period.

次要结局

  • SOFA Score(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • RBC (Red Blood Cell Count)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Hemoglobin (Hb)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Blood Ammonia(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Lactate(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • WBC (White Blood Cell Count)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • ALT (Alanine Aminotransferase)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • AST (Aspartate Aminotransferase)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Total Bilirubin (TBIL)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Direct Bilirubin (DBIL)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • ALP (Alkaline Phosphatase)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • BUN (Blood Urea Nitrogen)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Serum Creatinine (Scr)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Albumin (ALB)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Glucose (GLU)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Prothrombin Time (PT)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Prothrombin Activity (PTA)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • International Normalized Ratio (INR)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Activated Partial Thromboplastin Time (APTT)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Platelet Count (PLT)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Glasgow Coma Scale (GCS)(From completion of CiPS-BAL therapy through Week 12 post-treatment (assessed at 1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, and Week 12).)
  • Change from baseline in Model for End-Stage Liver Disease (MELD) score(Baseline; 0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after CiPS-BAL therapy)
  • Glasgow Coma Scale (GCS)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • SOFA Score(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • APACHE II Score(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Lactate(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Alpha-Fetoprotein (AFP)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Ceruloplasmin(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Blood Ammonia(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • RBC (Red Blood Cell Count)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Hemoglobin (Hb)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • WBC (White Blood Cell Count)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Platelet Count (PLT)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • ALT (Alanine Aminotransferase)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • AST (Aspartate Aminotransferase)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Total Bilirubin (TBIL)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Direct Bilirubin (DBIL)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • ALP (Alkaline Phosphatase)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • BUN (Blood Urea Nitrogen)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Serum Creatinine (Scr)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Albumin (ALB)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Glucose (GLU)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Prothrombin Time (PT)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Prothrombin Activity (PTA)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • International Normalized Ratio (INR)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)
  • Activated Partial Thromboplastin Time (APTT)(0.5-1 hour, 12 hours, 24 hours, Day 2, Day 3, Day 5, Day 7, Week 2, Week 4, Week 6, Week 12, Month 6, and Month 12 after treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Li-Ying Sun

Director of Department of Critical Liver Diseases

Beijing Friendship Hospital

研究点 (1)

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