Hepatocyte Transplantation as a Life Support Bridge
|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|
- Survival to liver transplantation
- Liver Function Normalization
|Study Start Date:||May 2000|
|Estimated Study Completion Date:||January 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282542
|Principal Investigator:||Robert A Fisher, MD, FACS||VCU Health System|