Human Gene Therapy Subcommittee - 11/21-22/91 
CALL TO ORDER 
Dr. Walters, Chair, called the meeting of the Human Gene Therapy Subcommittee 
(HGTS) of the Recombinant DNA Advisory Committee (RAC) to order at 9:00 a.m., 
November 21, 1991. He stated that five protocols would be reviewed. Four protocols 
are being presented today and can be classified as either gene marking or gene therapy. 
However, one protocol being reviewed today, adds an additional parameter that makes 
classification difficult. He asked the HGTS for assistance in classifying Dr. Greenberg's 
protocol that includes the introduction of a gene that would allow ablation of the cells 
should untoward results occur, and additional comments regarding classification of 
protocols. 
Mr. Capron suggested that when considering protocols that fall under the category of 
gene therapy, perhaps genetic enhancement of circulating cells should be separated from 
the treatment of genetic disease. The HGTS should distinguish between the treatment 
of genetic and non-genetic diseases when categorizing gene therapy experiments. Dr. 
Miller said that all of the treatment protocols should be categorized as gene therapy 
without further division. Dr. Leventhal said that distinctions would be important for 
categories no longer needing review by the HGTS; until that time, written distinctions 
were not necessary. 
Dr. Walters said that there would be reports from two working groups of the HGTS 
today, the Working Group on New Approaches for Gene Therapy and the Working 
Group on Data Management. Dr. Walters explained the protocol review procedures. 
Primary and secondary reviewers would comment first, other committee member 
comments next, followed by discussion by the committee, questions from the floor, and 
finally the investigators would have an opportunity to respond. 
Dr. McGarrity noted for the public record that he was now associated with Genetic 
Therapy, Inc., which is supplying vectors to Drs. Economou and Cometta. 
PROPOSED AMENDMENT TO APPENDIX D OF THE NIH GUIDELINES 
REGARDING A HUMAN GENE TRANSFER PROTOCOL ENTITLED THE 
TREATMENT OF PATIENTS WITH METASTATIC MELANOMA AND RENAL CELL 
CANCER USING IN VITRO EXPANDED AND GENETICALLY-ENGINEERED 
(NEOMYCIN PHOSPHOTRANSFERASE) BULK, CD8(+) AND/OR CD4(+) TUMOR 
INFILTRATING LYMPHOCYTES AND BULK, CD8(+ ) AND/OR CD4(+ ) 
PERIPHERAL BLOOD LEUKOCYTES IN COMBINATION WITH RECOMBINANT 
INTERLEUKIN-2 ALONE, OR WITH RECOMBINANT INTERLEUKIN-2 AND 
RECOMBINANT ALPHA INTERFERON /Dr. Economou: 
Review— Dr. Miller 
Recombinant DNA Research, Volume 15 
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