Recombinant DNA Advisory Committee - 09/14-15/92 
review. The language in the informed consent document should be modified to ask 
permission to perform an autopsy rather that requiring that an autopsy be performed. 
Dr. Deisseroth had responded to Ms. Meyers' concerns regarding the importance of the 
gene marking/ ABM research satisfactorily. However, she mentions an increasing 
concern among the genetic disease consumer group that funding for genetic research is 
inadequate, whereas funding for cancer research is excessive in comparison. Concern 
about these perceptions is important from a public policy standpoint for NIH. Many 
protocols reviewed by the RAC require the patient to pay for procedures that are 
expected to have no therapeutic value, this requirement raises moral and ethical issues 
that have not been adequately addressed. The bone marrow marking studies may 
provide answers to important scientific questions that are applicable to many diseases. 
Unfortunately, many patients with hereditary life-threatening disorders will not live long 
enough to benefit from the answers. This research would appear less biased if protocols 
were presented at future RAC meetings involving diseases other than AIDS and cancer. 
Finally, she was concerned about what could be done to encourage the submission of 
other types of protocols? 
Dr. Parkman noted that this CLL protocol differs from previously submitted protocols in 
that CD34 cells, stem cells, will be positively selected in addition to the negative 
selection of the CD19(-) B cells. However, the CD19 selection process was inadvertently 
omitted from the final protocol. A description of the complement lysis procedure should 
be included in the final version of the protocol. He inquired about the relevant 
efficiency of the two types of purging used. 
Dr. Post asked for clarification regarding which particular vector, LNL6 or GINa, will be 
used to transduce either the marrow or peripheral blood cell populations. Dr. Haselkom 
asked the investigators to expand on the magnetic bead selection procedure. Dr. Murray 
inquired about the status of Dr. Deisseroth's previously approved protocols. Have the 
studies been initiated? How many patients have been enrolled? Dr. Murray called on 
Dr. Deisseroth to present a summary of the proposed experiment and to respond to the 
RACs questions and comments. 
Presentation-Dr. Deisseroth 
Dr. Deisseroth explained that this protocol is designed to determine the origin of relapse 
in the ABM transplant setting. Two similar, yet distinguishable, safety modified vectors 
will be used to evaluate the independent multiple steps used to remove abnormal cell 
populations. These two steps are CD19(-) selection and CD34( + ) selection. The 
negative selection process is designed to remove the unwanted CLL cells, whereas the 
positive selection procedure retains the normal cells. 
This CLL protocol differs qualitatively from other protocols in that it involves the 
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