Hepatocyte Transplantation in Liver Failure

This study has been withdrawn prior to enrollment.
(Investigator taking position at another university-0 enrolled under this protocol.)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00805610
First received: December 5, 2008
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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: 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.

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. ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00805610

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

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00805610     History of Changes
Other Study ID Numbers: VCU IRB 124
Study First Received: December 5, 2008
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014