I. 
II. 
Human Gene Therapy Subcommittee - 7/30/90 
CALL TO ORDER AND INTRODUCTORY REMARKS; j 
j 
Dr. Walters (Chair) called the meeting of the Human Gene Therapy j 
Subcommittee of the Recombinant DNA Advisory Committee to order j 
at 9:00 a.m., July 30, 1990. He called the subcommittee's j 
attention to the brochure entitled Gene Therapy for Human j 
Patients which explains the workings of the Recombinant DNA I 
Advisory Committee (RAC) and the Human Gene Therapy Subcommittee j 
(HGTS) in lay language. He said the purpose of the document is 
to provide information to the general public on human gene j 
therapy. I 
Dr. Walters informed the subcommittee that the Institutional I 
Biosafety Committee (IBC) at the University of Wisconsin had not I 
met to act on Dr. Cornetta ' s proposal. Therefore the agenda for j 
the day would include: | 
I: 
1. The proposal on adenosine deaminase (ADA) deficiency by| 
Drs. Blaese, Anderson and Culver; | 
I 
2. The proposal concerning tumor necrosis factor (TNF) by j 
Drs. Rosenberg, Blaese and Anderson; and, 
3. The proposal concerning human gene transfer in i 
autologous bone marrow transplantation by Dr. Brenner, 
et al . , from St. Jude Children's Hospital. 
i 
I 
PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING 
HUMAN GENE THERAPY PROTOCOL ENTITLED "TREATMENT OF SEVERE 
COMBINED IMMUNODEFICIENCY DISEASE (SCID) DUE TO ADENOSINE 
DEAMINASE (ADA) DEFICIENCY WITH AUTOLOGOUS LYMPHOCYTES TRANSDUCED 
WITH A HUMAN ADA GENE! i 
Dr. Walters called on Dr. Parkman to present a review of the | 
protocol. Dr. Parkman said provisional approval of this protocol j 
had been granted at the last meeting with eight conditions to be ! 
met. Dr. Epstein asked that the conditions be restated so that 
the discussion could be focused. 
j 
Dr. Wivel said the motion to approve this protocol was 
unanimously passed with the following eight provisos: 
i 
1. That the consent form be revised, be reviewed and 
accepted by the RAC at its next meeting; 
2. That a stronger warning with regard to the potential 
for malignancy be inserted in the consent form; 
[60] 
Recombinant DNA Research, Volume 14 
