HEPATOCELLULAR TRANSPLANTATION AND TARGETING GENETIC MARKERS TO HEPATIC CELLS 
I 
I' 
7. Psychosocial evaluation. Psychosocial issues are important in the evaluation and ' 
selection of patients and families for conventional OLT and psychological or social 
interventions are commonly offered to these families. Patients involved in the present i 
protocol will receive the same considerations as those participating in OLT. ^ A: 
ii' 
8. Informed consent. All of the patients included in the present study will be minors. ; j| 
Informed consent from parents or guardians is required for inclusion in the study. I 
Assent forms will be prepared and will be used at the discretion of the patient's I. j* 
primary physician and Principle Investigator. . 
B. Harvest and Cultivation of Hepatocytes. ■ 1 
Hepatocytes will be harvested post mortem from individuals who have provided consent j 
for conventional organ donation. We anticipate most samples will come from organ donors i, 
in the Houston area where the liver cannot be used for transplantation because of 
traumatic damage or from right hepatic lobes available after reduced liver ' 
transplantation. Livers will not be used for the present experimental study if they can I 
be used from conventional OLT. The donor liver will be flushed with Belzer's solution i 
(Southard et al, 1990) using conditions identical to those used for conventional OLT 
(Olthoff et al, 1990). We anticipate that this harvest will often be coincident with 
harvest of other organs including heart or kidneys and will employ routine harvest i 
procedures. Hepatocytes will not be harvested from patients with hepatic disease by 
history, clinical examination, or histological examination; a history of hepatitis; j 
documented hepatic ischemia; evidence of IV drug use; CMV; or AIDS. (These criteria are | 
similar to those employed for OLT.) There is no tissue typing in conventional OLT and i, 
organs are matched only for ABO compatibility and size. We will not select organs on i; 
the basis of sex or ethnic origin. ! 
A blood sample and biopsy of the donor organ will be obtained at the time of j, 
harvest. The biopsy will be subject to histological examination. Blood will be used j 
for CBC, CHEM20 (if not on donor's medical record), tissue typing, blood typing, and j 
serologies to identify evidence of past or present infection with hepatitis A and B | 
virus, HIV, cytomegalovirus (CMV), herpes simplex virus (HSV) , Epstein Barr virus (EBV), j|j 
or Varicella Zoster virus (VZV) infection. A portion of the donor liver will be i- 
routinely cultured viruses of clinical importance including picornaviruses , CMV, HSV, 
VZV, adenoviruses, influenza virus, parainfluenza virus, and respiratory syncytial | 
virus. Additional studies to identify potential infectious agents harbored in the ! 
isolated hepatocytes may include immunofluorescent assays for CMV early antigen or 
hepatitis antigens and PGR analysis for genomes of CMV, hepatitis, or HIV. If 
serologies available in the 72 hours between organ harvest and transplantation indicate 
the presence of hepatitis A, hepatitis B, CMV, or HIV in the donor, the sample will not 
be used for transplantation. Positive serologies for other infectious agents would not 
be a contraindication for use of the donor organ. The additional diagnostic studies for 
infectious diseases will be performed in order to assess the contribution of infectious : 
complications to the success or failure of the transplant. * 
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Recombinant DNA Research, Volume 14 
