Recombinant DNA Advisory Committee - 03/1-2/93 
simplex - thymidine kinase/ganciclovir system for this study. The comparison of 
methodologies that was included in the submission was informative. 
Other Comments 
Ms. Meyers stated that the informed consent document is very well written and that her 
comments are minor. The parent and patient informed consent documents should 
include the statement, "The patient will not derive any personal benefit from this 
protocol; however, knowledge will be gained which will benefit others." The document 
should include a statement regarding patient follow-up. All gene transfer patients should 
be followed for life and suggested that the NIH establish a patient registry. A request 
for autopsy in the event of accidental death should be included in the parent informed 
consent document. Statements should be included about financing, confidentiality, access 
to records, and statements about contraception and pregnancy, i.e., for teenagers. 
Dr. Zallen responded to Ms. Meyers comment about the establishment of a gene transfer 
registry. Dr. Zallen inquired about an appropriate course of action that the RAC could 
take regarding the establishment of gene transfer registry. Dr. Walters reminded the 
RAC members that Dr. Fred Ledley, Texas Medical Center, Houston, Texas, previously 
submitted a proposal to the RAC regarding a human gene transfer patient registry for 
information purposes. Dr. French Anderson, University of Southern California, Los 
Angeles, California, stated that he has worked with Dr. Ledley for approximately 10 
years in an effort to obtain financial support for a patient registry. However, because of 
the current budget cuts, the registry may not be supported by the NIH. Dr. Leventhal 
said that it is not appropriate to discuss the future of a patient registry during the 
discussion of Dr. Heslop's protocol, and the RAC should focus their comments on the 
EBV-specific CTL study. 
Dr. Walters inquired as to whether this protocol is considered a therapeutic or a 
trafficking study. Dr. Heslop responded that this protocol is a Phase I study; therefore, 
efficacy will not be determined. Dr. Heslop stated that although it would be encouraging 
if an effect was observed from the adoptive transfer of these EBV-specific CTL, this 
protocol is solely a marking study. 
Dr. Leventhal explained that human gene transfer and therapy protocols should be 
categorized by the function of the gene that is inserted. Since the gene transferred for 
this study encodes for neo R , which has no therapeutic potential, this protocol should be 
considered gene transfer. 
Committee Motion 
A motion was made by Dr. DeLeon and seconded by Dr. Leventhal to approve the 
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