HEPATOCELLULAR TRANSPLANTATION AND TARGETING GENETIC MARKERS TO HEPATIC CELLS 
Table 9. Follow-up tests (see also Appendix E) 
Conventional laboratory tests of hepatic function and injury. 
Conventional laboratory tests of hematological status, 
CEA, AFP, immunoglobulin electrophoresis 
If indicated from positive previous studies: 
HIDA scanning (if clinical indicated or previously abnormal) 
Bone marrow aspirate (if clinically indicated or previously abnormal) 
CT scan (if previously abnormal) 
EEC (if clinically indicated or previously abnormal) 
Immunological studies for mediators of rejection 
For the first year of the protocol, or thereafter if abnormal: 
Collection of stool, urine, and sputum, for viral particle analysis. 
Collection for blood for analysis of antibodies against viral vectors. 
Longitudinal psychosocial evaluation (see below) . 
3. Role of the primary care provider: If HCT is successful, the primary health care 
provider will become an important focus of continuing surveillance, patient tracking, 
contact, and follow-up; especially if patients live far from Houston. In order to 
involve and inform the primary care providers, the primary physician will be contacted 
by the Principle Investigator and invited to participate in discussions of the patient's 
course prior to transplantation and will be appraised on a regular basis of evaluations 
in the GCRC. 
The primary health care providers will also find themselves an important link to the 
community with regard to the gene transfer aspects of this protocol, both as a local 
source of information to the community and as a conduit of information to the research 
center. Thus, it is particularly important that the primary care providers understand 
the process, potential, and problems of gene transfer in human subjects, the relative 
magnitude of risk and benefits, and the rationale behind the procedures performed on 
their patients and be able to explain this to community if necessary. The primary care 
provider will be given articles from the lay literature describing somatic gene therapy 
as well as review articles from the medical literature written for practicing physicians 
(e.g. Ledley, 1987a; 1987b). It would also be beneficial for primary care providers, 
who are not from the Houston area, to meet with hospital public relations for briefing 
concerning issues which may arise in the community. 
4. Genetic counselling. Families will be informed about the theoretical risk of 
vertical transmission as part of the informed consent (see below) . We will recommend 
that genetic counselling be given to the subjects at adolescence when sexual activity 
begins. We will also indicate that it may be appropriate to repeat this counselling at 
the discretion of the subject with a partner as part of pre- conceptual genetic 
counselling. (Since many of our patients will be young children, we believe that there 
will be considerably more data available concerning any potential risks of gene transfer 
by the time these patients are old enough to consider genetic counselling.) 
5. Psychosocial studies. We will assess the social dynamics and psychosocial 
development of study subjects on an ongoing basis as part of a research project to 
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