Clinical trial NCT01108380: Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells
Official title: Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells Transplantation in the Patient Needed Extensive Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Liver cirrhosis
liver regeneration
liver volume
liver function
hepatocellular carcinoma, extensive
hepatectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2010-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Safety and efficacy, short term outcome
timeFrame: 4 weeks after procedure
Secondary outcomes:
measure: Safety and efficacy.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Ho-Seong Han
state: Gyeonggi-do
Study officials:
affiliation: Chairman of surgery, Seoul National University Bundang Hospital
name: Ho-Seong Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: