This will be a randomized double blind study which will be conducted on patients admitted to Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline. 60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30 patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1 year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg twice a week for 2 months. Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3 months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis.
Time frame: 1 Year
Histopathological evidence of hepatic regeneration and mobilization of CD34/stem cells
Time frame: 1 Year
Histopathological evidence of contribution of bone marrow precursor cells in hepatic regeneration and the markers predicting positive response to growth factors
Time frame: 1 Year
Development of new complications such as appearance or worsening of hepatic encephalopathy, hepatorenal syndrome and sepsis.
Time frame: 1 Year
Improvement in severity assessment scores and safety profile of G-CSF (Growth-Colony Stimulating Factor) + EPO (Erythropoetin)dual therapy vs. G-CSF alone.
Time frame: 1 Year
Transplant free survival at 6 months in both groups
Time frame: 6 months
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