Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01108380
First received: April 20, 2010
Last updated: December 14, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention
Liver Cirrhosis
Procedure: Plasma pheresis, Right portal vein embolization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells Transplantation in the Patient Needed Extensive Hepatectomy

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Safety and efficacy, short term outcome [ Time Frame: 4 weeks after procedure ] [ Designated as safety issue: Yes ]
    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:
  • Safety and efficacy. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. CD34
  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.
Procedure: Plasma 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.

Other Name: COBE BCT Inc : for plasmapheresis
Active Comparator: 2. Mononucelar cell
  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.
Procedure: Plasma 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.

Other Name: COBE BCT Inc : for plasmapheresis
3. Control
Without infusion of G-CSF, patients will be performed just right portal vein embolization
Procedure: Plasma 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.

Other Name: COBE BCT Inc : for plasmapheresis

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108380

Contacts
Contact: Ho-Seong Han, PhD 82-31-787-7099 hanhs@snubh.org
Contact: Keun Soo Ahn, MD 82-31-787-7099 ahnks@snubh.org

Locations
Korea, Republic of
Ho-Seong Han Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Ho-Seong Han, PhD Chairman of surgery, Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Ho-Seong Han. Chairman of surgery department. Seoul National University Bundang Hospital, Surgery department
ClinicalTrials.gov Identifier: NCT01108380     History of Changes
Other Study ID Numbers: SNUBH-GS-HBP3, B-0901-068-003
Study First Received: April 20, 2010
Last Updated: December 14, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Liver cirrhosis
liver regeneration
liver volume
liver function
hepatocellular carcinoma, extensive
hepatectomy

Additional relevant MeSH terms:
Liver Cirrhosis
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 23, 2014