Hepatocyte Transplantation in Liver Failure
The investigators research will examine the safety and efficacy of hepatocyte transplantation in the patient with acute liver failure without history of chronic disease. The investigators will study the effectiveness in providing a bridge of support for patient survival until whole organ transplantation is possible. This support may also be a bridge to recovery; by allowing the native liver to recover so that orthotopic liver transplant is not necessary.
The investigators will also study the safety and efficacy of hepatocyte transplantation in the patient with chronic liver disease. Underlying etiologies of chronic disease may arise from cirrhosis, fibrosis or inherited metabolic disorders. The investigators will examine cell transplantation in end-stage patients not eligible for whole organ transplant. These patients may benefit with an amelioration of symptoms that will allow other therapeutic treatments.
The investigators study will also examine the ability of transplanted hepatocytes to treat inherited metabolic diseases (ex., Crigler-Najjar Disease, Familial Hypercholesterolemia, Urea Cycle Disorders). Cell transplant may also act as a 'bridge' to whole organ transplant or improve function, permitting easier disease control through traditional therapy.
|Study Design:||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.|
- The functional capability of transplanted hepatocytes to assume function in the native liver. [ Time Frame: Outcome measurements will be assessed weekly through week two post transplant, then monthly through month 12, then every six months. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Hepatocyte Transplantation
Hepatocyte Transplantation through single donor will be transplanted into the liver via intraportal or intrasplenic routes.
Biological: Hepatocyte Transplantation
Briefly, prepared hepatocytes from a single donor will be transplanted into the liver via intraportal or intrasplenic routes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805610
|Contact: Donna Y Winborne, BSN||(804) firstname.lastname@example.org|
|Contact: Robert A Fisher, M.D.||(804) email@example.com|
|United States, Virginia|
|Virginia Commonwealth University Health System||Not yet recruiting|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Robert A Fisher, M.D.||Virginia Commonwealth University Health System|