Status:
COMPLETED
Safety and Efficacy Study of Peripheral Blood Mononucleated Cells for Treatment of Liver Cirrhosis
Lead Sponsor:
Seoul National University Hospital
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
20-79 years
Phase:
PHASE1
Brief Summary
The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for the treatment of patients with advanced liver cirrhosis.
Detailed Description
G-colony stimulating factor(5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis. On the day 4th, plasmapheresis will be done to collect peripheral bl...
Eligibility Criteria
Inclusion
- 20 =\< Age \< 80
- 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
- HBsAg-positive
- Active status of hepatocellular carcinoma (HCC) (except patients who have no radiologic evidence of remnant HCC for more than 2 years after treatment)
- History of hemochromatosis and/or autoimmune hepatitis
- Pregnant women or lactating women
- 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
- Serum creatinine\> 1.5 x normal upper limit or creatinine clearance \<60 ml/min
- Presence of signs of malignant tumors or tumor suspected symptoms, or history of malignant tumors with recurrence rate greater than 20% within two years
- Gastrointestinal bleeding within the last 3 months or if there is a history of spontaneous bacterial peritonitis
- Presence of portal vein thrombosis
- Presence of acute infections
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01503749
Start Date
January 1 2012
End Date
August 1 2014
Last Update
December 19 2014
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