Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01108380

Enrollment

Registered

2010-04-22

Start date

2009-01-31

Completion date

2011-12-31

Last updated

2010-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosis, liver regeneration, liver volume, liver function, hepatocellular carcinoma, extensive, hepatectomy

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

Interventions

PROCEDUREPlasma pheresis, Right portal vein embolization

Plasma pheresis : With insertin of 2 intravenous line, plasmapheresis will be done with COBE BCT Inc. It will be performed under supervision of clinical laboratorians and doctors. Right portal vein : Under ultrasonography guided, left portal vein be punctured. Right portal vein will be embolized by coil or gelfoam.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Contacts

Primary ContactHo-Seong Han, PhD

hanhs@snubh.org82-31-787-7099

Backup ContactKeun Soo Ahn, MD

ahnks@snubh.org82-31-787-7099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026