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

NCT01503749 | Completed Phase 1 Results

• 1 other identifier: PBMC
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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)

  up to 6 months

Secondary Outcomes (1)

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

  Baseline and Week 24

Study Arms (3)

Control

NO INTERVENTION

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

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

Drug: G-colony stimulating factor

Infusion of the mobilized monocyte cells

EXPERIMENTAL

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.

Other: Infusion of the mobilized monocyte cells

Interventions

G-colony stimulating factor DRUG

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

Also known as: Filgrastim

G-colony stimulating factor

Infusion of the mobilized monocyte cells OTHER

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.

Also known as: Filgrastim, leukapheresis

Infusion of the mobilized monocyte cells

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• =\< 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Filgrastim; Leukapheresis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Results Point of Contact

• Title: Pf. Jung-Hwan Yoon
• Organization: Seoul National University Hospital

yoonjh@snu.ac.kr

82-2-2072-2228

Study Officials

• Jung-Hwan Yoon, M.D., Ph. D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 4, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2014
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-10