These cleansed and marked marrow cells will be used to 
restore normal marrow function after intensive therapy. 
Bone marrow will be taken (about two quarts) from the pelvis 
and possibly sternum under general anesthesia. A small 
amount of extra blood (one tablespoon full) may be removed 
for studies after the transplant to follow the marking 
procedure, but this will not require additional 
venipunctures over and above that which is already required 
to follow transplant recovery. Thirty percent of the stored 
marrow cells will be mixed with a specially engineered mouse 
virus which cannot cause an infection in the body. This 
virus will mark cells with a bacterial gene that makes it 
possible to find these cells. This "marked" marrow will be 
added to the rest of the marrow and returned to the 
circulation after intensive therapy. 
The therapy will be given during the transplant and in the 
event of relapse would be the same as if the patient had not 
been given the marrow marked with the virus. Ten patients 
will participate in this clinical research study. Marrow 
aspirations specifically for this clinical research study 
will be collected every three to four weeks after recovery 
for the first six months and then at six monthly intervals 
after that. Thereafter, routine bone marrow samples will be 
obtained and a portion used for this research. 
RISKS, SIDE EFFECTS AND DISCOMFORTS TO PARTICIPANTS: 
Extensive study of this virus marking procedure has been 
undertaken in mice and monkeys. This virus and another like 
it are currently being studied at other institutions. No 
adverse effects have been observed in all of this study 
because the virus is modified so that it cannot cause an 
infection in the cells of the body. It only marks a small 
number of blood cells in the autologous marrow. 
Risks, however, which may not yet have been observed, are 
possible. These are "theoretical risks" since they have not 
yet been seen. It is possible that the virus could change 
the cells which are marked so as to grow in an abnormal 
pattern, and even cause cancer or leukemia. This risk is 
much lower than damage to the cells by chemotherapy and 
irradiation. The marker might also produce a protein which 
might inactivate certain antibiotics but alternative 
antibiotics are available so that this does not constitute a 
risk or threat for patients during therapy. 
4a. This clinical research may involve unforeseeable risks 
to the participant (or to the embryo or fetus, if the 
participant is or may become pregnant during 
treatment) . To help prevent injury to unborn children, 
upon recommendation by the attending physician, the 
participants should practice adequate methods of birth 
■ control throughout the period of their involvement in 
Recombinant DNA Research, Volume 16 
