Human Gene Therapy Subcommittee - 11/21-22/91 
Ms. Meyers expressed concern about the reviewers receiving unacceptable information 
about the vector after voting approval. Dr. Erickson said that the HGTS is an advisory 
group to RAC; therefore, the approval was tentative. Mr. Capron said the RAC should 
be able to decide approval based on receipt of satisfactory data. Dr. Miller said his 
concern was more with receiving the information and discharging his duty than it was 
with the vector. 
Dr. Mclvor asked if TIL populations had been transduced with LNL6 and GINa, then 
scaled-up to large numbers in order to mimic the conditions under which patients would 
be treated. Dr. Economou replied that transduced cells had been kept in culture for 
approximately three months and that these long-term TIL exhibited stable vector 
integration. However, TIL were not grown up to large numbers due to the cost 
associated with large expansions. 
Dr. Miller asked if the percentage of vector-marked cells remained unaltered over the 
growth period. Dr. Economou replied that the percentage of vector-marked cells 
remained constant at approximately 5%. Dr. Miller stated that the HGTS should have 
seen these data. Mr. Capron suggested that an amendment to Dr. Leventhal's motion 
should be added concerning data on vector marking in long term cultures of TIL. Dr. 
Leventhal concurred. Item number five in Dr. Leventhal's motion for approval would 
be: 
(5) data should be provided showing stable integration of markers in expanded cell 
populations in long-term culture. 
Dr. Walters asked Dr. Wivel to summarize the motion that was on the table for the 
HGTS in preparation to vote on Dr. Economou's protocol. Dr. Wivel restated the Dr. 
Leventhal's motion for conditional approval based on the five points stated earlier. 
Dr. Walters called for a vote. The motion passed by a vote of 9 in favor, 1 opposed, and 
1 abstention. Dr. Parkman stated that he had abstained since one of the co-investigators 
was a member of his division. 
PROPOSED AMENDMENT TO APPENDIX D OF THE NIH GUIDELINES 
REGARDING A HUMAN GENE THERAPY PROTOCOL ENTITLED 
IMMUNOTHERAPY OF MALIGNANCY BY IN VIVO GENE TRANSFER INTO 
TUMORS /Dr. Nabel: 
Review~Dr. Epstein 
Dr. Walters called on Dr. Epstein to present his primary review of the protocol 
submitted by Dr. Gary Nabel of the University of Michigan Medical School, Ann Arbor, 
Recombinant DNA Research, Volume 15 
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