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

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ClinicalTrials.gov Identifier: NCT01503749
Recruitment Status : Completed
First Posted : January 4, 2012
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Liver Cirrhosis
Interventions: Drug: G-colony stimulating factor
Other: Infusion of the mobilized monocyte cells

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment location: single medical center (Seoul National University Hospital) Recruitment period: between February 2012 and July 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Number of total enrolled pariticipants: 9 Number of screened participants: 14 Number of dropped participants: 5 (Withdraw consent:4, etc:1 due to development of hepatocellular carcinoma) Number of completed participants: 9

Reporting Groups
  Description
Control

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

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.

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

Infusion of the Mobilized Peripheral Blood Mononucleated 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.

Infusion of the mobilized peripheral blood mononucleated 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.


Participant Flow:   Overall Study
    Control   G-colony Stimulating Factor   Infusion of the Mobilized Peripheral Blood Mononucleated Cells
STARTED   3   3   3 
COMPLETED   3   3   3 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control

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

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.

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

Infusion of the Mobilized Peripheral Blood Mononucleated 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.

Infusion of the mobilized peripheral blood mononucleated 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.

Total Total of all reporting groups

Baseline Measures
   Control   G-colony Stimulating Factor   Infusion of the Mobilized Peripheral Blood Mononucleated Cells   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   3   9 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   2   2   1   5 
>=65 years   1   1   2   4 
Age 
[Units: Years]
Mean (Full Range)
 57 
 (45 to 65) 
 62 
 (59 to 68) 
 63.3 
 (54 to 71) 
 60.8 
 (45 to 71) 
Gender 
[Units: Participants]
       
Female   1   2   1   4 
Male   2   1   2   5 
Region of Enrollment 
[Units: Participants]
       
Korea, Republic of   3   3   3   9 


  Outcome Measures

1.  Primary:   Number of Participants With Severe Adverse Events   [ Time Frame: up to 6 months ]

2.  Secondary:   Mean Change in Child-Pugh Score and Model For End-Stage Liver Disease (MELD) Score   [ Time Frame: Baseline and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Pf. Jung-Hwan Yoon
Organization: Seoul National University Hospital
phone: 82-2-2072-2228
e-mail: yoonjh@snu.ac.kr



Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01503749     History of Changes
Other Study ID Numbers: PBMC
First Submitted: January 2, 2012
First Posted: January 4, 2012
Results First Submitted: November 27, 2014
Results First Posted: December 19, 2014
Last Update Posted: December 19, 2014