Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells

Liver Cirrhosis Clinical Trial

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

Status Unknown status

Clinical Trial Summary

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.

Clinical Trial Description

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.

3. 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.

4. Allocation: We will allocate patients randomly to three group including control group.

5. 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 ;

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

• NCT number: NCT01108380
• Study type: Interventional
• Source: Seoul National University Hospital
• Contact: Ho-Seong Han, PhD
• Phone: 82-31-787-7099
• Email: hanhs@snubh.org
• Status: Unknown status
• Phase: N/A
• Start date: January 2009
• Completion date: December 2011