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VI . OSHA STATEMENT 
This protocol conforms with the OSHA/HHS guidelines for HIV/HBV occupational 
safety. 
VII. INFORMED CONSENT 
<par 1> After reviewing the course of your child's liver disease, your physicians have 
determined that this disease is life threatening and is not responding adequately to 
conventional medical management. Your child has been evaluated as a candidate for 
surgical whole organ liver transplantation, and your physicians have described to you 
that while whole organ transplant might benefit your child, it is not now available. 
<par 2> As part of your evaluation in the Clinical Research Center, your physicians 
have determined that you are eligible for an experimental alternative to whole organ 
liver transplantation called hepatocellular transplantation or liver cell injection. 
This experimental therapy involves injection of healthy liver cells purified from a 
donor liver (that cannot be used for whole organ transplant) into your child's liver. 
This procedure has been developed by physicians and researchers at the Texas Children's 
Hospital and the Baylor College of Medicine, and this is the first time it will be 
attempted in patients. This liver cell injection may provide a sufficient number of 
healthy liver cells to carry out the functions that your child's damaged liver can no 
longer adequately perform. This may provide a long-term cure for your child's disease 
or may provide a temporary source of liver functions capable of supporting your child 
until your child's liver recovers or the option of whole organ transplantation can be 
reconsidered. It is possible that this procedure will not work in your child. This 
will not repair the damage that your child's liver has already suffered, but can provide 
essential liver functions and restore a more normal quality of life. 
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