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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. Identifier: NCT00282542
Recruitment Status : Withdrawn
First Posted : January 26, 2006
Last Update Posted : January 31, 2017
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Fulminant Liver Failure Procedure: Hepatocyte Infusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure
Study Start Date : May 2000
Study Completion Date : January 2006

Primary Outcome Measures :
  1. Survival to liver transplantation

Secondary Outcome Measures :
  1. Liver Function Normalization

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria: Patients with Sepsis


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00282542

Sponsors and Collaborators
Virginia Commonwealth University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Robert A Fisher, MD, FACS VCU Health System

Layout table for additonal information Identifier: NCT00282542     History of Changes
Other Study ID Numbers: VCU124
First Posted: January 26, 2006    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Virginia Commonwealth University:

Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Liver Diseases
Digestive System Diseases