Hepatocyte Transplantation in Liver Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00805610|
Recruitment Status : Withdrawn (Investigator taking position at another university-0 enrolled under this protocol.)
First Posted : December 9, 2008
Last Update Posted : August 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Failure||Biological: Hepatocyte Transplantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure.|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2018|
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.
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805610
|United States, Virginia|
|Virginia Commonwealth University Health System|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Robert A Fisher, M.D.||Virginia Commonwealth University Health System|