Human Gene Therapy Subcommittee - 7/30/90 
Dr. Epstein asked if Dr. Rosenberg could have the consent form 
amended by the following day for the meeting of the RAC to 
include any changes discussed during the day, as well as those 
mentioned in Mr. Capron's letter. Dr. Rosenberg agreed that he 
would work on the consent form and have an amended consent form 
ready by the time the RAC begins its considerations. 
Dr. Miller noted that if the subcommittee had concerns about 
local concentration effects that would cause unanticipated 
toxicity, that they urge a lowering of dose, or a decreased 
number of cells to be administered or a greater period between 
administration of the cells. He said that he felt the protocol 
was very conservative, but that any concerns should be 
quantitative in nature. These could be ameliorated by dose 
reduction, rather than by restricting or prohibiting the 
protocol . 
There being no further discussion, the motion was put to a vote. 
The motion passed by a vote of 13 in favor, none opposed and no 
abstentions. 
Whereupon, Dr. Walters called for a brief recess before 
continuing with the next agenda item. 
Dr. Walters reconvened the subcommittee at 3:40 p.m., and asked 
Dr. Leventhal to begin discussion of the next agenda item. 
PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING 
HUMAN 
GENE 
TRANSFER < 
CLINICAL 
PROTOCOL ENTITLED "USE OP 
MARKER 
GENES 
TO INVESTIGATE 
THE BIOLOGY OF MARROW RECONSTITUTION AND 
RELAPSE OF 
MALIGNANT 
DISEASE 
FOLLOWING AUTOLOGOUS BONE 
MARROW 
TRANSPLANTATION ; 
Dr. Leventhal said the objectives of the study are to determine: 
1. Whether the source of relapse after autologous bone 
marrow transplantation (ABMT) for marrow derived 
malignancies is residual malignant cells in the 
harvested marrow or in the patient; 
2. Whether the majority of cases of acute myelogenous 
leukemia (AML) which lack genetic markers represent 
abnormalities in a multilineage cell; and, 
3. What are the mechanisms of autologous reconstitution 
and the effects of stimuli (including growth factors) 
that modify the process. 
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Recombinant DNA Research, Volume 14 
