Recombinant DNA Advisory Committee - 10/16/90 
with ORDA staff, but found the minutes to be an accurate 
reflection of what transpired at the July 31, 1990 meeting. 
Dr. McGarrity noted that he had requested that the actual vote 
tally from a vote which was stated in the minutes as passing by a 
"majority vote" be amended to show the exact tally of the vote. 
Dr. Wivel said this had been done. 
Dr. Mclvor moved that the minutes be accepted as modified. Dr. 
Brewer seconded the motion. The motion passed by a vote of 17 in 
favor, zero against and 1 abstention. 
Dr. McGarrity noted that at this point he wished to modify the 
agenda. He noted that Dr. W. French Anderson was in attendance 
and was prepared to present a progress report on the human gene 
therapy trial in progress regarding treatment of adenosine 
deaminase (ADA) deficiency. He asked Dr. Anderson to make his 
presentation at this point. 
III. PROGRESS REPORT ON HUMAN GENE THERAPY PROTOCOL ON ADA DEFICIENCY: 
Dr. Anderson said the first patient to enter the protocol was a 4 
year old girl who had her initial treatment with ADA-corrected T 
lymphocytes on September 14, 1990. He noted there were no side 
effects noted with this treatment. He said she received her 
second treatment on October 15, 1990, again with no apparent side 
effects. He noted that Dr. McGarrity had been afforded the 
opportunity to visit the patient on the 15th and had also met her 
father and been able to have a brief discussion with them. 
Mr. Garner asked how long this process of apheresis and treatment 
would continue. Dr. Anderson replied that the protocol calls for 
monthly infusions at current levels up to six months. At six 
months, if everything continues going well, the number of 
injected cells will be escalated and the investigators will begin 
to look for therapeutic effects. This process is expected to 
continue for approximately 18 months. Dr. Anderson noted that a 
second patient has been selected and the decision on when to 
enter this patient into the trial will be made within two weeks. 
Dr. McGarrity thanked Dr. Anderson for the opportunity to meet 
the patient and for the tour of the facilities that he was given. 
He noted that seeing an actual patient who is being treated gives 
one a broader perspective on the deliberations and decisions of 
the RAC. 
IV. PROPOSED REVISION OF APPENDIX K OF THE ”NIH GUIDELINES" REGARDING 
LARGE-SCALE EXPERIMENTS; 
Dr. McGarrity called on Dr. Riley to discuss this agenda item. 
Recombinant DNA Research, Volume 14 
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