NCT00282542

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2000

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2006

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

First QC Date

January 20, 2006

Last Update Submit

January 30, 2017

Conditions

Fulminant Liver Failure

Keywords

Hepatocytes

Outcome Measures

Primary Outcomes (1)

  • Survival to liver transplantation

Secondary Outcomes (1)

  • Liver Function Normalization

Interventions

Hepatocyte InfusionPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Robert A Fisher, MD, FACS

    VCU Health System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 26, 2006

Study Start

May 1, 2000

Study Completion

January 1, 2006

Last Updated

January 31, 2017

Record last verified: 2017-01