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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Medical treatment | Active Comparator | Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups. |
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| Single cycle of G-CSF + darbepoetin and standard medical treatment | Experimental |
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| Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month) | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darbepoetin | Drug | Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in innate immunity between the groups. | Innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants developed new-onset of LRE (such as ascites, HE, AKI, bleed and sepsis) or show mortality in all the groups. | 6 months | |
| Cumulative incidence of second decompensation in all the groups. | 6 months & 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Shreya Singh, MD | Contact | 01146300000 | shreyasingh2746@gmail.com | |
| Dr Manoj Kumar Sharma, DM | Contact | 01146300000 | manojkumardm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Manoj Kumar Sharma, DM | Institute of Liver and Biliary Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences (ILBS) | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| G-CSF | Drug | 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 |
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| Lactulose | Drug | Standard Medical Tretament part |
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| Albumin | Biological | Standard Medical Tretament part |
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| Transplant-free survival. | 6 months & 1 year |
| Number of participants with improvement in liver disease severity indices (CTP). | 6 months |
| Number of participants with improvement in liver disease severity indices (MELD). | 6 months |
| Number of participants with change in adaptive immunity(T-cell, B-cell and NK cells distribution only ) | 6 months |
| Number of participants with change in inflammation (a panel of pro and anti-inflammatory cytokines). | 6 months |
| Change in gcsf levels and EPO levels at baseline and completion of each cycle. | 6 months |
| Proportion of participants completing treatment without major adverse effects; | 6 months |
| Number of participants with change in peripheral blood CD34+ Hematopoietic Stem Cells count at 6months. | 6 months |
| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D007792 | Lactulose |
| D000418 | Albumins |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D000073893 | Sugars |
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