search
Back to results

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Withdrawn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
Virginia Commonwealth University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fulminant Liver Failure focused on measuring Hepatocytes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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)
    search

    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    Withdrawn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

    We'll reach out to this number within 24 hrs