Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282542
Status:
WITHDRAWN
Last Update Posted:
2017-01-31
First Post:
2006-01-20
Brief Title:
Hepatocyte Transplantation as a Life Support Bridge
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure
Status:
WITHDRAWN
Status Verified Date:
2017-01
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:
The purpose of this study is to gain knowledge about the result of infusing liver cells carefully matched to blood type into a subjects body The hope is that this procedure will aid functions of the liver and prevent death enable a transplant procedure to be carried out if a donated liver becomes available and lessen complications in postoperative recovery There is no guarantee that any of these benefits will be re eived but even if they are not the hope is that knowledge gained by using this procedure will be of future benefit to others who also suffer from liver disease
Detailed Description:
Adult and pediatric patients eligible for liver transplantation who require intensive care unit admission for multisystem organ failure in addition to liver failure without systemic sepsis are eligible for liver cell transplantation regardless of race sex or financial support
Failure of 3 or more organ systems are the criterion used to select patients with as close to 100 mortality as possible without solid organ transplant
Hepatocytes isolated from excess liver tissure from reduced liver transplant procedures or from donor livers not used for transplantation are prepared by a complex process and then are infused guided by radiology into the splenic artery or portal vein of the patient Patients must be on immunosuppression therapy for as long as the hepatocytes are living and beneficial to the patient
Failure of 3 or more organ systems are the criterion used to select patients with as close to 100 mortality as possible without solid organ transplant
Hepatocytes isolated from excess liver tissure from reduced liver transplant procedures or from donor livers not used for transplantation are prepared by a complex process and then are infused guided by radiology into the splenic artery or portal vein of the patient Patients must be on immunosuppression therapy for as long as the hepatocytes are living and beneficial to the patient
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