跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT01108380
NCT01108380Unknown不适用

Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells Transplantation in the Patient Needed Extensive Hepatectomy

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年1月1日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Safety and efficacy, short term outcome
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

For patient with liver cirrhosis who need to right or extended right hepatectomy, we will treat with autologous peripheral stem cells transplantation to facilitate liver regeneration. We will asses liver regeneration by evaluation of liver volume and liver function test.

详细描述

  1. Patients: 30 patients (10 patients in each 3 group)
  2. Indication:
  • Patients with Primary hepatocellular carcinoma combined liver cirrhosis (Hepatitis B, C, Non-B Non-C)
  • Planned to right hepatectomy or extended right hepatectomy
  • Patients who need right portal vein embolization due to insufficient expected remnant liver volume (< 40%) or severe hepatic dysfunction(ICGR15>10%)
  • Child A classification
  • ICG R15 < 25%
  • Age : 20 - 70 years old
  • Expected life period > 3months
  • The patients who agreed to this study.
  1. Contraindication
  • Patients who planned liver transplantation
  • Age <20 or >70 years old
  • Pregnant women
  • Patients on acute infection
  • Acute hepatic failure
  • Child class B or C
  • Heart failure
  • Existence of bleeding tendency : platelet < 30,000, INR > 2.2, Cr >2.5
  • Patients who did not agree to this study.
  1. Allocation: We will allocate patients randomly to three group including control group.
  2. Methods
  • Group 1: 4 days injection of G-CSF -> Plasma pheresis, Selection of CD34 cell -> Right portal vein embolization and infusion of CD34 cell into left portal vein.
  • Group 2: 4 days injection of G-CSF -> Plasma pheresis -> Right portal vein embolization and infusion of mononuclear cell into left portal vein.
  • Group 3 (control): Right portal vein embolization

( -> after 4 weeks, operation will be performed) 6. Evaluation: Change of liver volume, liver function test before and after portal vein embolization

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 70 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Patients with Primary hepatocellular carcinoma combined liver cirrhosis (Hepatitis B, C, Non-B Non-C)
  • •Planned to right hepatectomy or extended right hepatectomy
  • •Patients who need right portal vein embolization due to unsufficient expected remnant liver volume (< 40%) or severe hepatic dysfunction (ICG R15 > 10%)
  • •Child A classification
  • •ICG R15 < 25%
  • •Age: 20 - 70 years old
  • •Expected life period > 3months
  • •The patients who agreed to this study

排除标准

  • •Patients who planned liver transplantation
  • •Age < 20 or > 70 years old
  • •Pregnant women
  • •Patients on acute infection
  • •Acute hepatic failure
  • •Child class B or C
  • •Heart failure
  • •Existence of bleeding tendency : platelet < 30,000, INR > 2.2, Cr >2.5
  • •Patients who did not agree to this study

研究组 & 干预措施

1. CD34

Experimental
  1. 4 days injection of G-CSF (10μg/kg, Subcutaneous infusion)
  2. On 5th day, plasmapheresis will be performed to select mononuclear cells. (at least 4x10(9) of mononuclear cells)
  3. CD 34 cells will be selected by CliniMACS (Miltenyi Biotec, Bergisch- Gladbach, Germany) (at least 1x10(7) of CD 34 cell)
  4. In same day, right portal vein embolization with infusion of CD 34 cells into left portal vein will be performed.

干预措施: Plasma pheresis, Right portal vein embolization (Procedure)

2. Mononucelar cell

Active Comparator
  1. 4 days injection of G-CSF (10μg/kg, Subcutaneous infusion)
  2. On 5th day, plasma pheresis will be performed to select mononuclear cells. (at least 4x10(9) of mononuclear cells)
  3. In same day, right portal vein embolization with infusion of mononuclear cells into left portal vein will be performed.

干预措施: Plasma pheresis, Right portal vein embolization (Procedure)

3. Control

Other

Without infusion of G-CSF, patients will be performed just right portal vein embolization

干预措施: Plasma pheresis, Right portal vein embolization (Procedure)

结局指标

主要结局

Safety and efficacy, short term outcome

时间窗: 4 weeks after procedure

After portal vein embolization, we will compare liver volume by CT and liver function test by blood test in 3 groups. (Second and forth week)

次要结局

  • Safety and efficacy.(12 weeks)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Unknown
1 期
Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCsLiver Regeneration
NCT02327832Yamaguchi University Hospital10
终止
1 期
Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal CellsLiver Cirrhosis
NCT00913289Kanazawa University6
已完成
3 期
Long Term Follow up Mesenchymal Stem Cell Therapy for Patients Virus-related Liver CirrhosisLiver Cirrhosis
NCT05080465Ukraine Association of Biobank700
已完成
不适用
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal CellsLiver Cirrhosis
NCT01062750Kanazawa University4
已完成
2 期
Mesenchymal Stem Cell Transplantation in Decompensated CirrhosisCirrhosis
NCT00476060University of Tehran27