Page No. 
E. Isolation and Transduction of Hepatocytes 
1 . Hepatocyte Isolation and Primary Culture 3 8 
2. Retroviral Transduction Procedure of Primary FH 
Hepatocytes 3 8-39 
3. Analysis of Transduced Hepatocytes 3 9 
F. Delivery of Hepatocytes 3 9-41 
G. Evaluation of Engraftment 4 1 
1 . Metabolic consequences of gene transfer 41-43 
2. Molecular analyses of liver tissue 4 3 
H. Evaluation of Rejection 
1 . Identification of Possible Immunologic Consequences of Autologous 
Cell Transfer 4 3-44 
2. Monitoring and Detection of Immune Responses to Transduced Cell Proteins 44-45 
IV. Overall Assessment of Risks vs. Benefits 
A. Potential Efficacy of Gene Therapy 4 6-47 
B. Risks of Hepatic Resection and Hepatocyte Infusion 4 7 
C. Risks of Gene Transfer and Gene Expression 4 8-49 
D. Summary of Risks and Benefits 4 9 
V. References 50-56 
VI. Informed Consent 
A Adult 5 7-61 
B. Child 62-66 
C. Assent Form 6 7 
VII. Responses to "Points to Consider" 
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