Recombinant DNA Advisory Committee - 7/31/90 
this as a friendly amendment. 
There being no further discussion. Dr. McGarrity put the motion 
to a vote. The motion passed by a vote of 17 in favor, 0 
opposed, and no abstentions. 
Proposed Addition to Appendix D of the "NIH Guidelines" 
Regarding Human Gene Transfer Clinical Protocol entitled "Use of 
Marker Genes to Investigate the Biology of Marrow Reconstitution 
and Relapse of Malignant Disease Following Autologous Bone 
Marrow Transplantation; 
Dr. McGarrity said this item was deferred by the HGTS in its 
meeting yesterday, but asked whether Drs. Mulligan or B. Murray 
would like to make comments on it beyond the fact that it was 
deferred. 
Dr. Mulligan said that this was another gene marking approach, 
using autologous bone marrow transplantation to ask important 
questions about metastatic cancer cells. In certain treatment 
protocols, one removes bone marrow for later reinsertion after 
high-dose chemotherapy. If cancer recurs in such patients, 
either the chemotherapy was not adequate or there were residual 
cancer cells in the bone marrow sample. The concept is to mark 
the sample by a retrovirus infection and then reconstitute it. 
If a relapse of the cancer occurs, it is important to know if one 
can or cannot detect the marked cells. If marked cells are 
detected, it is apparent the bone marrow sample contained 
residual cancer cells; if no marked cells are present, then the 
treatment of the patient was adequate. 
Dr. Mulligan said that the concept was sound and sensible but 
that safety issues surrounding the manipulations of the cells in 
vitro would affect their capacity for transplantation or growth 
of the cancer. He said the authors did not supply any in vitro 
data as to how they were going to do the retroviral infections 
which was key in determining the ability of the marrow to 
reconstitute. The investigators were given some questions to 
answer and asked to submit a revised protocol based on those 
answers. Furthermore, there was discussion of whether the 
investigation should be more focused in that they proposed to 
study different cancers. No real consensus was reached on 
whether there should be separate proposals for each type of 
tumor. However, more in vitro data was required for an 
assessment of the protocol. 
Dr. B. Murray asked if the minutes of the subcommittee meeting in 
reference to this would be included in those issues to be 
appended to the RAC minutes as Dr. McGarrity had indicated 
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Recombinant DNA Research, Volume 14 
