Safety and Efficacy Study of Peripheral Blood Mononucleated Cells for Treatment of Liver Cirrhosis

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for the treatment of patients with advanced liver cirrhosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Lenograstim; Sargramostim

Criteria

Inclusion Criteria:

1. 20 =< Age < 80

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:

1. HBsAg-positive

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