Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells
NCT ID: NCT01108380
Last Updated: 2010-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2009-01-31
2011-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
3. Control
Without infusion of G-CSF, patients will be performed just right portal vein embolization
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
70 Years
ALL
Yes
Sponsors
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Seoul National University Bundang Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Surgery department
Principal Investigators
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Ho-Seong Han, PhD
Role: PRINCIPAL_INVESTIGATOR
Chairman of surgery, Seoul National University Bundang Hospital
Locations
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Ho-Seong Han
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Other Identifiers
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B-0901-068-003
Identifier Type: OTHER
Identifier Source: secondary_id
SNUBH-GS-HBP3
Identifier Type: -
Identifier Source: org_study_id