Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147043
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2005-09-05
Brief Title:
Adult Stem Cell Therapy in Liver Insufficiency
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Adult Stem Therapy for Patients With Liver Insufficiency
Status:
COMPLETED
Status Verified Date:
2019-10
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:
In order to determine the clinical application potential of adult stem cells we propose to investigate the safety and toxicity of infusing adult stem cells in the hepatic artery or portal vein of five patients with chronic liver insufficiency and to identify any clinical benefit if such occurs
Objectives
1 To assess safety and treatment related toxicities
2 To determine clinical benefit or deterioration by monitoring changes in liver function
Objectives
1 To assess safety and treatment related toxicities
2 To determine clinical benefit or deterioration by monitoring changes in liver function
Detailed Description:
The liver in an adult healthy body maintains a balance between cell gain and cell loss Though normally proliferatively quiescent hepatocyte loss such as that caused by partial hepatectomy uncomplicated by virus infection or inflammation invokes a rapid regenerative response to restore liver mass This restoration of moderate cell loss and wear and tear renewal is largely achieved by hepatocyte self-replication More severe liver injury can activate a potential stem cell compartment located within the intrahepatic biliary tree giving rise to cords of bipotential so-called oval cells within the lobules that can differentiate into hepatocytes and biliary epithelial cells A third population of stem cells with hepatic potential reside in the bone marrow these haematopoietic stem cells can contribute to the albeit low renewal rate of hepatocytes make a more significant contribution to regeneration and even completely restore normal function in a murine model of hereditary tyrosinaemia
A recent abstract has suggested that an astonishingly high number of bone marrow cells 25 of liver parenchyma occupied by bone marrow-derived cells will engraft and differentiate into hepatocytes in a model of cirrhosis in the mouse when injected intravenously More importantly this bone marrow infusion resulted in significant improvements in liver function serum albumin within the cirrhotic animals
This is a safety and toxicity study in five patients with chronic liver disease Each will receive autologous stem cells 10 to the sixth cells via the hepatic artery or portal vein under image guided scanning Patients will be followed for a total of 60 days
A recent abstract has suggested that an astonishingly high number of bone marrow cells 25 of liver parenchyma occupied by bone marrow-derived cells will engraft and differentiate into hepatocytes in a model of cirrhosis in the mouse when injected intravenously More importantly this bone marrow infusion resulted in significant improvements in liver function serum albumin within the cirrhotic animals
This is a safety and toxicity study in five patients with chronic liver disease Each will receive autologous stem cells 10 to the sixth cells via the hepatic artery or portal vein under image guided scanning Patients will be followed for a total of 60 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None