ClinicalTrials.gov
ClinicalTrials.gov Menu

Hepatocyte Transplantation as a Life Support Bridge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00282542
Recruitment Status : Withdrawn
First Posted : January 26, 2006
Last Update Posted : January 31, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Virginia Commonwealth University

January 20, 2006
January 26, 2006
January 31, 2017
May 2000
Not Provided
Survival to liver transplantation
Same as current
Complete list of historical versions of study NCT00282542 on ClinicalTrials.gov Archive Site
Liver Function Normalization
Same as current
Not Provided
Not Provided
 
Hepatocyte Transplantation as a Life Support Bridge
The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure
The purpose of this study is to gain knowledge about the result of infusing liver cells, carefully matched to blood type, into a subject's 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.

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.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fulminant Liver Failure
Procedure: Hepatocyte Infusion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
20
January 2006
Not Provided

Inclusion Criteria:

  • Patients admitted to VCU Health System ICU in fulminant Liver Failure in addition to multisystem organ failure

Exclusion Criteria: Patients with Sepsis

Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00282542
VCU124
Not Provided
Not Provided
Not Provided
Not Provided
Virginia Commonwealth University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Robert A Fisher, MD, FACS VCU Health System
Virginia Commonwealth University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP