Ignite Creation Date:
2024-05-06 @ 4:07 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02451033
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2015-05-12
Brief Title:
Granulocyte Colony Stimulating Factor And Growth Hormone In Cirrhosis Of Liver An Open Label Study
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Granulocyte Colony Stimulating Factor And Growth Hormone In Cirrhosis Of Liver An Open Label Study
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 fibrosisdysfunction 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None