Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells

Not Applicable

• Conditions: Liver Cirrhosis
• Interventions: Procedure: Plasma pheresis, Right portal vein embolization

• Registration Number: NCT01108380
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-14
• Last Update Posted: 2010-12-15
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. CD34	Plasma pheresis, Right portal vein embolization	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.
2. Mononucelar cell	Plasma pheresis, Right portal vein embolization	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.
3. Control	Plasma pheresis, Right portal vein embolization	Without infusion of G-CSF, patients will be performed just right portal vein embolization

Primary Outcome Measures

Name	Time	Method
Safety and efficacy, short term outcome	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)

Secondary Outcome Measures

Name	Time	Method
Safety and efficacy.	12 weeks	After 4 weeks of portal vein embolization, hepatectomy woul be performed in indicated patients. After hepatectomy, until 12 weeks, we will compare remnant liver volume by CT and liver function test by blood test.

Trial Locations

Locations (1)

Ho-Seong Han; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of