Hepatocyte Transplantation as a Life Support Bridge

Not Applicable

Withdrawn

• Conditions: Fulminant Liver Failure

• Registration Number: NCT00282542
• Lead Sponsor: Virginia Commonwealth University

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 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.

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.

Study Timeline

• Study Start: 2000-05
• Study Completion: 2006-01
• Study First Submitted: 2006-01-20
• Study First Submitted QC: 2006-01-25
• Study First Posted: 2006-01-26
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Patients with Sepsis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Survival to liver transplantation

Secondary Outcome Measures

Name	Time	Method
Liver Function Normalization