Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells

Seoul National University

Status: Unknown

Conditions: Liver Cirrhosis

Treatments: Procedure: Plasma pheresis, Right portal vein embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT01108380

SNUBH-GS-HBP3

B-0901-068-003 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

1. CD34

Experimental group

Description:

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.

Treatment:

Procedure: Plasma pheresis, Right portal vein embolization

2. Mononucelar cell

Active Comparator group

Description:

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.

Treatment:

Procedure: Plasma pheresis, Right portal vein embolization

3. Control

Other group

Description:

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

Treatment:

Procedure: Plasma pheresis, Right portal vein embolization