A Phase 2/3 interventional study of standard medical therapy and G-CSF in Cirrhosis, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 2 sites in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 2/3, Interventional, and Treatment
Cirrhosis of liver is a leading cause of morbidity and mortality worldwide . Complications including ascites, spontaneous bacterial peritonitis (SBP), variceal bleed, hepatic encephalopathy, hepatorenal syndrome (HRS) and development of hepatocellular carcinoma (HCC) have poor prognosis and further decreases the survival in these patients. It has been believed that cirrhosis is irreversible and that treatment should focus on preventing the progression of liver fibrosis/dysfunction and its complications.
Currently the only effective treatment is liver transplantation, an increasingly limited and expensive resource especially in developing countries. Furthermore, transplantation comes with a requirement for lifelong immunosuppression, and considerable long-term side effects that include chronic renal failure, post-transplant lymphoproliferative disease, and cardiovascular complications.
Short of liver transplant, recently, reports of unexpected plasticity in adult bone marrow have raised hopes that stem cell therapy may offer exciting therapeutic possibilities for patients with end stage liver diseases. It has been shown that in response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate the liver and differentiate into hepatic cells. Animal and human studies suggested that such cells might contribute to the regeneration after different kinds of liver injuries . In animal models, after liver injury, bone marrow-derived circulating pluripotent cells have been reported to participate in liver repopulation with both non-parenchymal cells and hepatocytes. This repopulation process, however, seems to be highly dependent on the type of liver injury and experimental conditions. Fusion with hematopoietic cells has been substantiated as a mechanism by which hepatocytes can regenerate, and studies have demonstrated improved liver histology and survival in patients with cirrhosis following mobilization of bone marrow stem cells by granulocyte-colony stimulating factor (G-CSF) . Three recent studies have demonstrated G-CSF induced mobilization of bone marrow stem cells (CD34 cells) in peripheral blood and their subsequent increase in liver tissue and improved survival in patients with alcoholic hepatitis and acute on chronic liver failure (ACLF) . However there is insufficient data on whether G-CSF improves survival and prognosis in patients with cirrhosis.
Also, Malnutrition is commonly seen (60-70%) in cirrhotics and have adverse prognosis on its outcome . The protein catabolic state of cirrhosis is associated with severe growth hormone (GH) resistance, with low levels of insulin-like growth factor (IGF)-I and its major binding protein (IGFBP)-3 . GH therapy in cirrhosis have been shown to improve nitrogen economy and to improve the GH resistance in a small pilot study. Also, GH therapy of short duration has shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis . GH therapy has also shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis . However there is scarcity of data on clinical impact of long term administration of GH therapy in patients of cirrhosis.
3,274 studies on the registry are indexed under Fibrosis; 466 are open to participants now.
This study's enrollment of 65 is above the median of 50 across 2,137 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 296 studies on the registry; 44 are open to participants now.
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Decompensated Cirrhosis of liver.
Exclusion Criteria:
Standard medical therapy
Drug: standard medical therapy
Standard medical therapy plus G-CSF at the dosage of 5 µg/Kg subcutaneously every 12 hr for five consecutive days then every 3 monthly for 3 days till 1 year.
Drug: standard medical therapy · Drug: G-CSF
Standard medical therapy plus G-CSF plus Growth Hormone therapy. Growth Hormone will be given in low dose of 1unit sc daily for 1 year.
Drug: standard medical therapy · Drug: G-CSF · Drug: Growth Hormone
diuretics, albumin infusion, antibiotics, nutrition, and variceal banding wherever needed
Drug pages: Granulocyte Colony-Stimulating Factor · Filgrastim
G-CSF at the dosage of 5 µg/Kg subcutaneously every 12 hr for five consecutive days then every 3 monthly for 3 days till 1 year
Growth Hormone in low dose of 1unit sc daily for 1 year
Transplant free survival
Survival at 1 year from the onset of therapy
Time frame: 1 year
haematopoietic stem cell mobilization
Mobilisation of CD34+ cells in peripheral blood
Time frame: 1 year
safety as measured by adverse effects of G-CSF, GH and combination in cirrhosis of liver
Adverse effects of G-CSF, GH and combination in cirrhosis of liver
Time frame: 1 year
Clinical/biochemical improvement in liver function profile
Improvement in prognostic scores - MELD score, and Child score
Time frame: 1 year
Ran from May 2015 to primary completion in Jun 2016, 13 months.
Of 18 phase 2/3 interventional studies under Fibrosis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's 13 months is below that.
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Granulocyte Colony-Stimulating Factor · Filgrastim · Growth Hormone
Post Graduate Institute of Medical Education and Research, Chandigarh →