NCT01108380

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 15, 2010

Status Verified

December 1, 2010

Enrollment Period

2.9 years

First QC Date

April 20, 2010

Last Update Submit

December 14, 2010

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosisliver regenerationliver volumeliver functionhepatocellular carcinoma, extensivehepatectomy

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy, short term outcome

    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)

    4 weeks after procedure

Secondary Outcomes (1)

  • Safety and efficacy.

    12 weeks

Study Arms (3)

1. CD34

EXPERIMENTAL

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

2. Mononucelar cell

ACTIVE COMPARATOR

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

3. Control

OTHER

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

Procedure: Plasma pheresis, Right portal vein embolization

Interventions

Plasma pheresis, Right portal vein embolizationPROCEDURE

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.

Also known as: COBE BCT Inc : for plasmapheresis
1. CD342. Mononucelar cell3. Control

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 unsufficient expected remnant liver volume (\< 40%) or severe hepatic dysfunction (ICG R15 \> 10%)
  • Child A classification
  • ICG R15 \< 25%
  • Age: 20 - 70 years old
  • Expected life period \> 3months
  • The patients who agreed to this study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ho-Seong Han

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisCarcinoma, Hepatocellular

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Blood Component RemovalTherapeuticsSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Ho-Seong Han, PhD

    Chairman of surgery, Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho-Seong Han, PhD

CONTACT

82-31-787-7099hanhs@snubh.org

Keun Soo Ahn, MD

CONTACT

82-31-787-7099ahnks@snubh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 22, 2010

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 15, 2010

Record last verified: 2010-12

Locations

KR(1)