Infusion of the liver cells: There are several risks from the infusion of cells. It is possible that 
infusion of cells would cause an infection, a blood clot, or possible bleeding. These 
complications may result in liver failure, and may require you to undergo a liver transplant. 
The clots in the blood vessels near the liver may make the liver transplantation difficult to 
perform. There are also risks involved with giving you cells that have been genetically 
corrected. Although the mouse virus that is used to insert the gene for the normal LDL receptor 
into your liver cells has been inactivated, it is possible that events may occur within your liver 
cells that result in the production of a new infectious virus or cancer of the liver. Because the 
technique of placing normal genes into cells is very new, it is also possible that this therapy 
may cause unforeseen problems. 
Period after leaving the hospital: The risks during this time involve the possibility of your 
body recognizing the new LDL receptor as foreign. Your body may try to reject these cells. This 
may result in the destruction of the infused, corrected liver cells. The function of the rest of 
your liver should not be affected. There may also be the previously mentioned risks of blood 
drawing. 
Confidentiality of Research Records: The principal investigator will keep a confidential 
record of your participation, which will be maintained and secured in the Clinical Research 
Center of the University of Michigan. Representatives of the National Institutes of Health, The 
Food and Drug Administration, or other regulatory agencies outside the University of Michigan 
will have access to your records. Your privacy will be protected by withholding your identity 
during any recording and reporting of this research. 
Alternatives to Participation: Your participation in this study is entirely voluntary and 
you can withdraw from the study at anv time. A decision not to participate will in no way 
jeopardize your health care, and you will continue to receive other therapies for your familial 
hypercholesterolemia as prescribed by your doctor. Alternative therapies for elevated blood 
"fats" involve taking medicine to lower the "fats" or repeatedly siphoning "fats" from your blood 
(plasmapheresis). Liver transplantation has also been shown to correct the defect in liver 
function in familial hypercholesterolemia. The physicians involved in this study can further 
explain these alternative forms of treatment and their risks and benefits to you. 
Cost to You: There will be no cost to you for your participation in this study. Any costs 
resulting from care you require as part of this study or because of complications from this 
study will be provided through the Clinical Research Center of the University of Michigan. 
Compensation for Illness or Injury: You will receive no compensation for any physical 
injury or illness that results from your participation in this study, but as previously stated, 
you will receive free treatment for these complications. 
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Recombinant DNA Research, Volume 15 
