Safety and Efficacy Study of Peripheral Blood Mononucleated Cells for Treatment of Liver Cirrhosis
NCT ID: NCT01503749
Last Updated: 2014-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2012-01-31
2014-08-31
Brief Summary
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Detailed Description
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. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Control
Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells.
No interventions assigned to this group
G-colony stimulating factor
G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.
G-colony stimulating factor
G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm.
Infusion of the mobilized monocyte cells
G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells
. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Infusion of the mobilized monocyte cells
G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Interventions
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G-colony stimulating factor
G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm.
Infusion of the mobilized monocyte cells
G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Advanced liver cirrhosis with Child-Pugh score 8 or 9 (including patients who have no radiologic evidence of remnant HCC for more than 2 years after treatment)
Exclusion Criteria
2. Active status of hepatocellular carcinoma (HCC) (except patients who have no radiologic evidence of remnant HCC for more than 2 years after treatment)
3. History of hemochromatosis and/or autoimmune hepatitis
4. Pregnant women or lactating women
5. Hemoglobin \< 8g/dL (male), 7.5g/dL (female) or white blood cell (WBC) \<1,500 mm3 or Neutrophils \<500/mm3 or platelet count \<50,000/mm3
6. Serum creatinine\> 1.5 x normal upper limit or creatinine clearance \<60 ml/min
7. Presence of signs of malignant tumors or tumor suspected symptoms, or history of malignant tumors with recurrence rate greater than 20% within two years
8. Gastrointestinal bleeding within the last 3 months or if there is a history of spontaneous bacterial peritonitis
9. Presence of portal vein thrombosis
10. Presence of acute infections
20 Years
79 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jung-Hwan Yoon, M.D., Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Countries
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Other Identifiers
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PBMC
Identifier Type: -
Identifier Source: org_study_id