Hepatocyte Transplantation as a Life Support Bridge

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00282542
First received: January 20, 2006
Last updated: January 25, 2006
Last verified: January 2006
  Purpose

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 Intervention
Fulminant Liver Failure
Procedure: Hepatocyte Infusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Survival to liver transplantation

Secondary Outcome Measures:
  • Liver Function Normalization

Estimated Enrollment: 20
Study Start Date: May 2000
Estimated Study Completion Date: January 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria: Patients with Sepsis

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282542

Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Robert A Fisher, MD, FACS VCU Health System
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00282542     History of Changes
Other Study ID Numbers: VCU124
Study First Received: January 20, 2006
Last Updated: January 25, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Hepatocytes

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

ClinicalTrials.gov processed this record on July 20, 2014