Hepatocyte Transplantation as a Life Support Bridge
Primary Purpose
Fulminant Liver Failure
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hepatocyte Infusion
Sponsored by
About this trial
This is an interventional treatment trial for Fulminant Liver Failure focused on measuring Hepatocytes
Eligibility 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 -
Sites / Locations
Outcomes
Primary Outcome Measures
Survival to liver transplantation
Secondary Outcome Measures
Liver Function Normalization
Full Information
NCT ID
NCT00282542
First Posted
January 20, 2006
Last Updated
January 30, 2017
Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00282542
Brief Title
Hepatocyte Transplantation as a Life Support Bridge
Official Title
The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fulminant Liver Failure
Keywords
Hepatocytes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hepatocyte Infusion
Primary Outcome Measure Information:
Title
Survival to liver transplantation
Secondary Outcome Measure Information:
Title
Liver Function Normalization
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Fisher, MD, FACS
Organizational Affiliation
VCU Health System
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Hepatocyte Transplantation as a Life Support Bridge
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