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

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Liver Cirrhosis

Treatments: Other: Infusion of the mobilized monocyte cells; Drug: G-colony stimulating factor

Study type: Interventional

Funder types: Other

Identifiers

NCT01503749

PBMC

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 9 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Control

No Intervention group

Description:

Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells.

G-colony stimulating factor

Active Comparator group

Description:

G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.

Treatment:

Drug: G-colony stimulating factor

Infusion of the mobilized monocyte cells

Experimental group

Description:

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.

Treatment:

Other: Infusion of the mobilized monocyte cells