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| Sponsors and Collaborators: |
Virginia Commonwealth University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00282542 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Fulminant Liver Failure |
Procedure: Hepatocyte Infusion |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure |
| Estimated Enrollment: | 20 |
| 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria: Patients with Sepsis
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Contacts and Locations More Information
| Study ID Numbers: | VCU124 |
| Study First Received: | January 20, 2006 |
| Last Updated: | January 25, 2006 |
| ClinicalTrials.gov Identifier: | NCT00282542 |
| Health Authority: | United States: Institutional Review Board |
|
Hepatocytes |
|
Liver Failure Liver Diseases Digestive System Diseases Liver Failure, Acute Hepatic Insufficiency |
