The Role of Peripheral Mononuclear Cells for Treatment of Advanced Liver Cirrhosis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 9
- Primary Endpoint
- Number of Participants With Severe Adverse Events
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
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.
Intervention: G-colony stimulating factor (Drug)
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.
Intervention: Infusion of the mobilized monocyte cells (Other)
Outcomes
Primary Outcomes
Number of Participants With Severe Adverse Events
Time Frame: up to 6 months
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)
Secondary Outcomes
- Mean Change in Child-Pugh Score and Model For End-Stage Liver Disease (MELD) Score(Baseline and Week 24)