"1. Transfer of the vector to tumor infiltrating 
lymphocytes or TIL from a suitable murine tumor system; 
"2. Detection of vector-marked TIL in recipient mice; 
"3. Analysis of retroviral replication, tumorigenesis , and 
other undesirable effects in recipient mice; 
"In addition, data should be presented demonstrating that: 
"1. The human TIL that are marked by the vector are 
representative of the relevant cell populations, and; 
"2. 'Dry run' tests with human TIL should be completed 
which demonstrate a lack of infectious helper virus by 
the most sensitive assays available." 
Dr. Walters said that in the telephone conference call on 
September 29, 1988, the members and consultants unanimously 
agreed that additional information was still required in order to 
make a proper evaluation of this proposal. He called on 
Dr. Neiman to present the summary statement which resulted from 
the conference call. 
Dr. Neiman distributed a written summary which he said 
represented both a summary statement and sense of the 
Subcommittee as a result of the July 29 and September 29, 1988, 
deliberations. He read the following statement: 
"The sense of the Subcommittee and outside consultants 
is supportive of the general concept of the use of 
recombinant vectors in gene transfer procedures for 
marking somatic cells in humans as an aid to the 
development of important new advances in clinical 
research. Because such procedures are not done 
primarily to benefit the subject and may in fact be of 
no benefit to the individuals involved, proposals to 
carry out these experiments must be supported by a 
clear data base demonstrating if a specific procedure 
planned is safe and likely to yield knowledge of value. 
"In the present case, knowledge likely to enhance 
further development of cancer immunotherapy with 
autologous human tumor infiltrating lymphocytes or TIL. 
Because the present proposal would be the first to 
involve human subjects and clearly sets precedence for 
proposals that follow, the Subcommittee views 
evaluation of the supporting data base as especially 
important . 
[236] 
Recombinant DNA Research, Volume 13 
