HGTS 7/29/88 
The Human Gene Therapy Subcommittee met on July 29, 1988, to consider the first 
human gene transfer proposal. Dr. W. French Anderson of the National Heart, Lung, and 
Blood Institute (NHLBI), Dr. Steven Rosenberg of the National Cancer Institutes (NCI), and 
Dr. Michael Blaese of NCI submitted the proposal. 
The major events since the proposal was first submitted to the NIH Clinical Research 
Subpanels are as follows: 
June 10, 1988 
Initial submission of what was technically an amendment of an 
approved clinical research project entitled "The Treatment of Patients 
with Advanced Cancer Using Cyclophosphamide, lnterleukin-2 and 
Tumor Infiltrating Lymphocytes," to two NIH Clinical Research 
Subpanels (NCI and NHLBI). 
June 15, 1988 
Proposed amendment submitted to NIH Institutional Biosafety 
Committee. 
June 20, 1988 
Initial review of proposed amendment by NCI Clinical Research 
Subpanel which approved the amendment with the stipulation that 
the final version of the proposal be resubmitted to the Subpanel for 
final consideration, and offered ten recommendations for further 
amendment of the proposal. 
June 21, 1988 
NHLBI Clinical Research Subpanel reviewed the amendment and 
approved it with three stipulations including: (1) that the Subpanel 
deferred to the RAC on procedures to ensure no infectious viral 
particles remained in the preparation; (2) that final approval was 
contingent upon investigators’ report of ongoing experiments to 
demonstrate the N2 infected cells were representative of the major 
group of uninfected TIL cells; and (3) the informed consent form be 
revised. 
July 5, 1988 
First mailing to Human Gene Therapy Subcommittee by ORDA. 
July 13, 1988 
Review of proposed amendment by NIH IBC with approval 
conditional upon RAC approval and receipt of results from 
preliminary work in vivo in the mouse. 
July 13, 1988 
Formal submission of proposed amendment to ORDA by Drs. 
Anderson, Blaese, and Rosenberg. 
July 18, 1988 
Second mailing to Human Gene Therapy Subcommittee by ORDA. 
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Recombinant DNA Research, Volume 13 
