Liver CirrhosisNCT01108380
Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells
A study testing Plasma pheresis, Right portal vein embolization in people with Liver Cirrhosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Plasma pheresis, Right portal vein embolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Heart failure
- Existence of bleeding tendency : platelet < 30,000, INR > 2.2, Cr >2.5
- Patients who did not agree to this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ho-Seong Han
Seongnam-si, Gyeonggi-do
About this study
Official title: Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells Transplantation in the Patient Needed Extensive Hepatectomy
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.
Read the detailed description
- Patients: 30 patients (10 patients in each 3 group)
- 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.
- 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.
- Allocation: We will allocate patients randomly to three group including control group.
- 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)
- Evaluation: Change of liver volume, liver function test before and after portal vein embolization
- Conditions
- Liver Cirrhosis
- Being tested
- Plasma pheresis, Right portal vein embolization
- Keywords
- Liver cirrhosis, liver regeneration, liver volume, liver function, hepatocellular carcinoma, extensive, hepatectomy
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma pheresis, Right portal vein embolizationProcedure or surgery
Also called COBE BCT Inc : for plasmapheresis
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Plasma pheresis, Right portal vein embolization |
| 3. Control | Other | Without infusion of G-CSF, patients will be performed just right portal vein embolization Receives: Procedure: Plasma pheresis, Right portal vein embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks after procedure
Secondary outcomes (1)
Safety and efficacy.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Investigators
- Ho-Seong Han, PhD, Principal investigator, Chairman of surgery, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108380
- Sponsor's protocol ID
- SNUBH-GS-HBP3
- Other IDs
- B-0901-068-003
- Status last verified
- Dec 2010
- First submitted
- 20 Apr 2010
- Last updated
- 15 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells Transplantation in the Patient Needed Extensive Hepatectomy
- ClinicalTrials.gov ID
- NCT01108380
- Acronym / sponsor ID
- SNUBH-GS-HBP3
- Conditions
- Liver Cirrhosis
- Keywords
- Liver cirrhosis, liver regeneration, liver volume, liver function, hepatocellular carcinoma, extensive, hepatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Patients: 30 patients (10 patients in each 3 group)
- 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.
- 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.
- Allocation: We will allocate patients randomly to three group including control group.
- 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)
- Evaluation: Change of liver volume, liver function test before and after portal vein embolization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. CD34 | Experimental | Procedure: Plasma pheresis, Right portal vein embolization1. 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. |
| 2. Mononucelar cell | Active comparator | Procedure: Plasma pheresis, Right portal vein embolization1. 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. |
| 3. Control | Other | Procedure: Plasma pheresis, Right portal vein embolizationWithout infusion of G-CSF, patients will be performed just right portal vein embolization |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (9 listed)
- Patients who planned liver transplantation
- Age < 20 or > 70 years old
- Pregnant women
- Patients on acute infection
- Acute hepatic failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma pheresis, Right portal vein embolizationAlso: COBE BCT Inc : for plasmapheresisPlasma 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. | Procedure or surgery | 1. CD34, 2. Mononucelar cell, 3. Control |
Primary outcome
Safety and efficacy, short term outcome
Time frame: 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)
1 secondary outcome
Safety and efficacy.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Seong Han, PhD principal investigator
Chairman of surgery, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma pheresis, Right portal vein embolization in people with Liver Cirrhosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho-Seong Han, PhD (82-31-787-7099, hanhs@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy, short term outcome (time frame: 4 weeks after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2010.