This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Hepatocyte Transplantation in Liver Failure

This study has been withdrawn prior to enrollment.
(Investigator taking position at another university-0 enrolled under this protocol.)
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: December 5, 2008
Last updated: August 1, 2014
Last verified: August 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 Intervention Phase
Liver Failure Biological: Hepatocyte Transplantation Phase 1 Phase 2

Study Type: Interventional
Study Design: 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.

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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. ]

Enrollment: 0
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)
Arms Assigned Interventions
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.


Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Inclusion criteria are specific to the classification of liver disease, i.e., fulminant or non-fulminant or metabolic disease

Exclusion Criteria:

  • Any systemic infection
  • Unstable coronary artery disease
  • HIV infection
  • Preformed antibodies to class antigens that are present on all available donor samples (Only cells from an ABO-compatible donor with no HLA Class I antigen to which the recipient has preformed antibodies will be selected for transplant.)
  • Hepatopulmonary disease (Room air Pa02 ≤ 60 mmHg)
  • Testing positive for Hepatitis B Surface Antigen (HBsAg), Hepatitis Be antigen (HBeAg) or Hepatitis B Virus by DNA and unable to receive or pay for Hepatitis B treatment.
  • Any current or anticipated contraindication for the use of tacrolimus and cyclosporine, methylprednisolone or prednisone.
  • Female patients who are breast feeding
  • Any medical condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00805610

United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Principal Investigator: Robert A Fisher, M.D. Virginia Commonwealth University Health System
  More Information

Responsible Party: Virginia Commonwealth University Identifier: NCT00805610     History of Changes
Other Study ID Numbers: VCU IRB 124
Study First Received: December 5, 2008
Last Updated: August 1, 2014

Keywords provided by Virginia Commonwealth University:
Liver Failure
Hepatocyte Transplantation
Liver Transplantation

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics processed this record on July 25, 2017