Status:
WITHDRAWN
Hepatocyte Transplantation in Liver Failure
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Liver Failure
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE1
PHASE2
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 t...
Eligibility Criteria
Inclusion
- Inclusion criteria are specific to the classification of liver disease, i.e., fulminant or non-fulminant or metabolic disease
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00805610
Start Date
June 1 2014
End Date
June 1 2018
Last Update
August 5 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298