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Withdrawn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
About this trial
This is an interventional treatment trial for Liver Failure focused on measuring Liver Failure, Hepatocyte Transplantation, Liver Transplantation
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.
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
NCT ID
NCT00805610
First Posted
December 5, 2008
Last Updated
August 1, 2014
Sponsor
Virginia Commonwealth University
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Withdrawn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
Learn more about this trial
Hepatocyte Transplantation in Liver Failure
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