Hepatocyte Transplantation in Liver Failure

NCT ID: NCT00805610

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-06-30

Brief Summary

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.

Conditions

Liver Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hepatocyte Transplantation

Hepatocyte Transplantation through single donor will be transplanted into the liver via intraportal or intrasplenic routes.

Group Type: EXPERIMENTAL

Hepatocyte Transplantation

Intervention Type: BIOLOGICAL

Briefly, prepared hepatocytes from a single donor will be transplanted into the liver via intraportal or intrasplenic routes.

Interventions

Hepatocyte Transplantation

Briefly, prepared hepatocytes from a single donor will be transplanted into the liver via intraportal or intrasplenic routes.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert A Fisher, M.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University Health System

Locations

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Countries

United States

Other Identifiers

VCU IRB 124

Identifier Type: -

Identifier Source: org_study_id