Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
2. It could readily have been produced by the patient’s clinical condition, 
environmental or toxic factors, or other modes of therapy administered to 
the patient. 
3. It follows a known response pattern to the use of immu no m agnetic 
purging. 
PR OR ABLE: This category applies to those adverse experiences that, after careful medical 
consideration at the time of evaluation, are felt with a high degree of certainty 
to be related to the in vitro gene marking and/or purging of marrow for 
infusion. An adverse experience may be considered probable if, for example: 
1. It follows a reasonable temporal sequence from reinfusion of 
marked/purged marrow. 
2. It could not be reasonably explained by the known characteristics of the 
patient’s clinical condition, environmental or toxic factors, or other modes 
of therapy administered to the patient. 
3. It follows a known pattern of response to the use of immunomagnetic 
purging. 
6.3.9 INFORMED CONSENT DOCUMENTS 
All patients and/or their legal guardian must sign a document of informed consent upon 
entry into the institution’s concurrent protocol. These documents are included in the 
concurrent protocols in Section 6.4. This will precede entry to this protocol. Informed 
consent must be consistent with local institutional and Federal guidelines and must 
indicate the investigational nature of the protocol and the possible side effects of 
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