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Hepatocyte Transplantation in Liver Failure

Primary Purpose

Liver Failure

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hepatocyte Transplantation
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Failure focused on measuring Liver Failure, Hepatocyte Transplantation, Liver Transplantation

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia Commonwealth University Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hepatocyte Transplantation

Arm Description

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

Outcomes

Primary Outcome Measures

The functional capability of transplanted hepatocytes to assume function in the native liver.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2008
Last Updated
August 1, 2014
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT00805610
Brief Title
Hepatocyte Transplantation in Liver Failure
Official Title
The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator taking position at another university-0 enrolled under this protocol.
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure
Keywords
Liver Failure, Hepatocyte Transplantation, Liver Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hepatocyte Transplantation
Arm Type
Experimental
Arm Description
Hepatocyte Transplantation through single donor will be transplanted into the liver via intraportal or intrasplenic routes.
Intervention Type
Biological
Intervention Name(s)
Hepatocyte Transplantation
Intervention Description
Briefly, prepared hepatocytes from a single donor will be transplanted into the liver via intraportal or intrasplenic routes.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Fisher, M.D.
Organizational Affiliation
Virginia Commonwealth University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Hepatocyte Transplantation in Liver Failure

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