Liver Failure Acute Clinical Trial
Official title:
Hepatocyte Transplantation for Acute Decompensated Liver Failure
The purpose of this research study is to determine whether liver cell transplantation can provide help for patients with liver failure who are unlikely to survive without some form of liver support. The goal of this research study is to determine if liver cell transplants can be effective until a liver transplant is received or until patients recover from their liver failure.
Orthotopic liver transplantation has become the treatment of choice for patients with acute
liver failure with poor prognostic signs. Survival following hepatic transplantation has
improved in the last decade for a number of reasons. These include improvement in
immunosuppression, improved methods for preserving and transporting organs, use of donors
which had been previously considered unacceptable, use of reduced-sized grafts , and the use
of living-donor hepatic transplantation. Despite encouraging survival statistics, there
continues to be significant morbidity and mortality associated with hepatic transplantation.
In addition, the success of hepatic transplantation has broadened the indications for this
form of therapy without a concomitant increase in the number of donors available for these
patients.
Since the development of a method for isolating primary hepatocytes by collagenase perfusion,
many investigators have demonstrated the efficacy of hepatocyte transplantation in the
treatment of liver failure and inherited metabolic disorders in experimental animals.
Treatment of liver diseases with transplantation of isolated hepatocytes rather than the
whole liver has several theoretical advantages. Unlike the whole liver, isolated hepatocytes
could be cryopreserved for instant availability and could be modified genetically or
otherwise to enhance specific functions, stimulate proliferation or abrogate allograft
rejection. Hepatocyte transplantation should be less stressful than whole liver
transplantation because the host organ remains intact. Since the transplanted cells integrate
into the host liver, they could provide restorative potential and the consequences of graft
loss would be relatively minor. In addition, hepatocyte transplantation would not interfere
with subsequent liver transplantation, should that become necessary.
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