Clinical trial NCT00805610: 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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Liver Failure
Keywords: Liver Failure
Hepatocyte Transplantation
Liver Transplantation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 0
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The functional capability of transplanted hepatocytes to assume function in the native liver.
timeFrame: Outcome measurements will be assessed weekly through week two post transplant, then monthly through month 12, then every six months.
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University Health System
name: Robert A Fisher, M.D.
role: PRINCIPAL_INVESTIGATOR
References: