Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells

Liver Cirrhosis Clinical Trial

Official title:

Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells Transplantation in the Patient Needed Extensive Hepatectomy

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01108380
• Other study ID #: SNUBH-GS-HBP3
• Secondary ID: B-0901-068-003
• Status: Unknown status
• Phase: N/A
• First received: April 20, 2010
• Last updated: December 14, 2010
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2010
• Source: Seoul National University Hospital
• Contact: Ho-Seong Han, PhD
• Phone: 82-31-787-7099
• Email: hanhs[@]snubh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ho-Seong Han	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 weeks