Human Gene Therapy Subcommittee - 11/30/90 
Parkman, and Mclvor to refine a description of the data requested by the HGTS for 
further consideration of the protocol. 
Dr. McCarthy suggested that one of the items that should be included is more 
background on the financial situation that exists in the State of Wisconsin relative to 
the consent document. Ms. Meyers said the informed consent document needed to 
be revised to clearly define realistic expenses that the patient may have and to 
clearly show whether the patient is financially supporting this research project. 
The subcommittee ended the session for lunch. A group of reviewers met during 
this time to devise a motion on the protocol. 
After lunch, Dr. Walters asked Dr. Parkman for a report from the group. Dr. 
Parkman said the consensus of the group was that deferral of the protocol was 
appropriate. The specific areas the investigators should consider addressing are: 
1. Define the purpose of the study more clearly by answering the following: 
a. If the present study has a positive outcome, what would be the 
next step taken? 
b. What would represent a positive outcome, in terms of the number 
of patients tested? and 
c. What is the definition of "positivity," in the sense of outcome? 
2. Provide results from six patients who have bone marrow containing 
leukemia cells in such a fashion so that one would be able to discern in 
a quantitative fashion the percentage of leukemic cells into which the 
neomycin resistance gene has been transfected. 
3. Supply greater detail on the methods of transfection. 
4. Describe in greater detail the techniques used for detection of marked 
cells including the primers, a map of the system, and actual results of 
PCR analysis performed under the auspices of the principal investigator, 
with a concise description of the sensitivity of the detection systems 
utilized. 
5. Provide clarification on what follow-up is going to take place. 
Recombinant DNA Research, Volume 14 
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