Recombinant DMA Advisory Committee - 5/30-31/91 
feasibility experiment proves successful that the next step would be to look at this issue. 
Further, he noted that such research on a new vector would best be performed with adult 
subjects, rather than children. 
Dr. R. Murray asked what tests were intended on being performed on the donor livers prior 
to transplantation. Dr. Ledley said they would be tested the same as any tissue prior to 
transplantation including tests for cytomegalovirus, hepatitis B virus and fflV. Dr. Murray 
asked that this information be included somewhere in the informed consent. Dr. Ledley 
agreed and said he would amend the informed consent form to include such information. 
Dr. Kelley asked what proportion of total hepatocytes was being contemplated for infusion 
into the patients. Dr. Ledley said that based on mathematical calculations assuming the 
patient to be a prototypical 70 kilogram person and if 10^° cells were infused, this would 
constitute approximately 5 percent of the total hepatocytes in the recipient. He said this 
figure matches both the baboon and dog experiments. However, he noted that in some of 
these patients with fulminant viral hepatitis, et cetera, they may have lost a significant 
proportion of their hepatocytes prior to induction and therefore the percentage could be much 
higher, but he added that in such cases the cells would be subject to the same growth factors, 
et cetera, present in the patient. He said further experimentation is required, but that of 
course the optimum would be for these induced cells to proliferate and repopulate the entire 
liver, but that he didn't suspect this would be the case. 
Dr. Mclvor then said that he was satisfied that the investigators had addressed all the issues 
and moved that the protocol be approved contingent upon the suggested changes in the 
consent document which were raised in the meeting. Dr. Bourquin seconded the motion. Dr. 
McGarrity then asked for further discussion on the motion. 
Dr. Kelley reiterated his concern that the investigators look at dil and determine whether or 
not it was an acceptable alternative hepatocellular marker. 
Dr. Mclvor suggested that the committee put together a list of all changes which need to be 
made to the consent form, so that both the investigators, as well as the RAC, are clear on 
exactly what will be done. The following listing was compiled by the committee: 
1. Deletion of the reference to measles and mumps; 
2. Insert the statement, "This will not necessarily help me, but may help others" in 
the assent form; 
3. Inclusion of information on the risk of CMV, HIV, hepatitis and other risk 
factors associated with the donor material in the informed consent form; 
4. On page 1455, paragraph 7, line 2, replace the term "genetic marker" with 
"bacterial marker." 
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Recombinant DNA Research, Volume 14 
