Exogenous growth factor-mobilized bone marrow (BM) stem cells(G-CSF) and DARBEPOETIN use have shown a differential response in the management of decompensated cirrhosis (DC) with improved survival, CTP and MELD scores. This study was designed to evaluate potential clinical benefit of repeated cycles of granulocyte-colony stimulating factor (G-CSF) and DARBEPOETIN versus single cycle on delta change in immunometabolic profile of patients at 6 months assessed in terms of -Change in innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation .
Aim: To study the efficacy of single vs repeated cycle of Granulocyte Colony Stimulating Factor+ darbopoetin vs standard medical treatmenton immunometabolic profile in patient with early decompensated cirrhosis Study population: * Age 18-70 years * Early decompensated cirrhosis MELD \< 16 , CTP \< 9B * Uncomplicated ascites * A Prospective Randomized Controlled Trial. * Single Centre. * Open label. * Block Randomization will be done , it will be implemented by IWRS method. * The study will be conducted in Department of Hepatology, ILBS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month
G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30
Standard Medical Tretament part
Standard Medical Tretament part
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India
RECRUITINGChange in innate immunity between the groups.
Innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation
Time frame: 6 months
Proportion of participants developed new-onset of LRE (such as ascites, HE, AKI, bleed and sepsis) or show mortality in all the groups.
Time frame: 6 months
Cumulative incidence of second decompensation in all the groups.
Time frame: 6 months & 1 year
Transplant-free survival.
Time frame: 6 months & 1 year
Number of participants with improvement in liver disease severity indices (CTP).
Time frame: 6 months
Number of participants with improvement in liver disease severity indices (MELD).
Time frame: 6 months
Number of participants with change in adaptive immunity(T-cell, B-cell and NK cells distribution only )
Time frame: 6 months
Number of participants with change in inflammation (a panel of pro and anti-inflammatory cytokines).
Time frame: 6 months
Change in gcsf levels and EPO levels at baseline and completion of each cycle.
Time frame: 6 months
Proportion of participants completing treatment without major adverse effects;
Time frame: 6 months
Number of participants with change in peripheral blood CD34+ Hematopoietic Stem Cells count at 6months.
Time frame: 6 months
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