Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
then once a year for 2 years. 
LONG-TERM FOLLOW UP 
We will follow your (your child’s) progress over a long period. You (your child) will need to 
be examined yearly for 14 years after the transplant. After the first 4 years this can be done by 
your (your child’s) local doctor. A teaspoon of blood will be taken at each exam. 
CONFIDENTIALITY 
Your (your child’s) case will be treated in complete confidence, unless you specifically agree 
otherwise. However, approved people from Government, outside agencies, or sponsoring 
organizations may review the charts. 
SIDE EFFECTS 
There are no known side effects of the virus, although we cannot rule out the possibility that it 
could cause some antibiotics not to work or could make cells cancerous. 
ALTERNATIVE PROCEDURES 
If you do not want to have part of your (your child’s) marrow marked, you (your child) could 
still have high-dose chemotherapy and bone marrow transplant. 
STATEMENT OF UNDERSTANDING 
The benefits of this experimental treatment are difficult to predict. It is possible that no useful 
information will be gained. However, we hope to learn more about your (your child’s) disease 
and improve treatment in the future. 
Recombinant DNA Research, Volume 16 
[493] 
