Human Gene Therapy Subcommittee - 11/21-22/91 
an animal model with preexisting bulk disease, (2) demonstrate the effect on distant 
preexisting tumor sites to simultaneous injection of tumor cells versus tumor cells plus 
fibroblasts, (3) demonstrate the effect of immune manipulation in a micrometastatic 
tumor model, (4) demonstrate the effect of irradiated tumor cells plus early passage 
primary fibroblasts, (5) generate transduction efficiency data, (6) demonstrate the 
percentage of selected fibroblasts that are actively synthesizing IL-2 in both mouse and 
human cells, and (7) demonstrate in an animal model that the injection of fibroblasts 
does not elicit an autoimmune response. 
A motion was made by Dr. Parkman and seconded by Dr. Miller to defer approval of 
the protocol. The motion passed by a vote of 13 in favor, 0 opposed, and no abstentions. 
VIII. REPORT FROM THE WORKING GROUP ON NEW APPROACHES TO GENE 
THERAPY 
Dr. Walters thanked the editor of The Journal of Medicine and Philosophy , Dr. H. 
Tristram Engelhardt, Jr., and the editor of the thematic issue on germ-line intervention, 
Dr. Eric Juengst, for granting the HGTS permission to view preprints of essays and 
abstracts from the issue on germ line genetic intervention. He also thanked Drs. W. 
French Anderson and John C. Fletcher for submitting a preprint that is to be published 
in Law, Medicine, and Health Care on this same topic. 
Report-Dr. Parkman 
Dr. Parkman stated that the HGTS decided the most logical place to begin discussion 
regarding germ line gene therapy was to review the topics that experts in the field have 
already discussed. Therefore, review of pertinent literature on this topic is a sensible 
starting point. There are three particular questions that the working group has focused 
on as central topics for discussion: (1) What are the areas in which the HGTS should 
obtain information in order to provide a background for these discussions? (2) What is 
the expected timeframe over which these discussions should occur? and (3) What 
categories would the HGTS put forward as beneficial uses of genetic intervention? Dr. 
Parkman gave an overview of the working group's discussions on these issues. 
Dr. Parkman said that the working group regarded the information on the present status 
of germ line gene therapy in large animals as critical information to review. How often 
is germ line transfer in large animals successful? Are there deleterious effects? Dr. 
Epstein asked for a clarification about what is meant by the phrase "therapy in large 
animals." Does this refer to transgenic animals? Dr. Parkman responded that transgenic 
animals would fall into this category. He referred specifically to homologous 
recombination with active germ line manipulation. Dr. Parkman said that the working 
group was interested in the present status of pre-implantation diagnosis experiments. 
Recombinant DNA Research, Volume 15 
[283] 
