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

Seoul National University Hospital9 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Cirrhosis

Interventions

G-colony stimulating factorDRUG

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 cellsOTHER

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Severe Adverse Events

No serious adverse event. Minor adverse events (not considered to be related to this study), as follows; Control: 6 events (ascites and pleural tapping, gum bleeding, ascties tapping x3, diarrhea) G-colony stimulating factor group: 6 events (percutaneous vertebroplasty, abdominal pain and nausea, hyperkalemia, ascties tapping, diarrhea, liver transplantation) Infusion of the mobilized peripheral blood mononucleated cells group: 1 event (hepatic encephalopathy)

Time frame: up to 6 months

Secondary Outcomes

Mean Change in Child-Pugh Score and Model For End-Stage Liver Disease (MELD) Score

The efficacy (mean change in Child-Pugh score and Model For End-Stage Liver Disease score \[at weeks 24\]) of ultrasound-guided percutaneous portal transplantation of peripheral blood monocyte cell in cirrhotic patients. MELD Score = (0.957 \* ln(Serum Cr) + 0.378 \* ln(Serum Bilirubin) + 1.120 \* ln(INR) + 0.643 ) \* 10 (if hemodialysis, value for Creatinine is automatically set to 4.0) (minimum \<9: 1.9% mortality; maximum 40 or more: 71.3% mortality). Child-Pugh score = Bilirubin (mg/dl): \<2 (1 point),2-3 (2 points), \>3 (3 points) + Albumin (g/dl): \>3.5 (1 point),3.5-2.8 (2 points), \<2.8 (3 points) + PT prolongation (INR): \<4 seconds (\<1.7) (1 point), 4-6 seconds (1.7-2.3) (2 points),\>6 seconds (\>2.3) (3 points) + Ascites: Absent (1 point), Slight (2 points), Moderate (3 points) + Encephalopathy: Absent (1 point), Mild (I-II) (2 points), Severe (III-IV) (3 points) ; Class A: 5-6, Class B: 7-9, Class C: 10-15 (minimum 5, maximum 15; higher Child-Pugh score with worse prognosis)

Time frame: Baseline and Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.