Hepatocyte Transplantation in Liver Failure
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 70 |
| Updated: | 5/5/2014 |
| Start Date: | June 2014 |
| End Date: | June 2018 |
| Contact: | Donna Y Winborne, BSN |
| Email: | dwinborne@mcvh-vcu.edu |
| Phone: | (804) 828-2463 |
The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure.
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.
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.
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.
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