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Hepatocyte Transplantation as a Life Support Bridge

The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00282542
Enrollment
0
Registered
2006-01-26
Start date
2000-05-31
Completion date
2006-01-31
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fulminant Liver Failure

Keywords

Hepatocytes

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.

Interventions

PROCEDUREHepatocyte Infusion

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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 \-

Design outcomes

Primary

MeasureTime frame
Survival to liver transplantation

Secondary

MeasureTime frame
Liver Function Normalization

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026