flNO 
/179 
9 /IT 5fi260 15M8 P.18 
hum.-^ns, ftlthougli our experience is limited because this form of experimentation is new. 
If lliis were to occur it could cause 0 serious Illness, possibly even cancer. To insure your 
safely, we have made the changed cells sensitive to an antibiotic called ganciclovir. This 
should destroy the gcnelirally altered cells (hat were injected into your Knuckle joints. 
2. You will undergo additional procedures as being part of this study, llic 
collection of joint fluid and injection of the cells prior to the four knuckle replacement 
may be painful. In addition, you will have 2 tablespoons of additional blood collected at 
several follow-up visits. Tlicrc is a sniull chance that the injected joint could get 
infected. Such an infection would be treatable by antibiotics. Frequent visits and an 
experienced surgeon will keep this risk to a minimum. 
TTius in the unlikely event that your changed cells wc give back to you cause some 
bad effect, you may be treated with the antibiotic ganciclovir through the vein. This 
would require hospital admission. Ganciclovir itself has a small associated risk including 
damage to the kidney. Consultation of an Infectious Disease Specialist (familiar with the 
use and side effects of ganciclovir) would keep this risk to a minimum in this unlikely 
circumsloncc. 
i. Premenopausal women who still have their uterus and ovaries (capable of 
bearing children) will not be accepted into this study. 
4. This study will he of no benefit to you personally. Nevertheless, knowledge 
may be gained to aid in an earlier cure to rheumatoid arthritis and other diseases of the 
joint. 
5. In the event of death at any time in the future, whether through accident, 
injury or illness, an autopsy will be requosfed. 
Al I KKNATIVE THERAPY 
The four knuckle joint replacement you will be receiving at the end of this study 
is the current slatc-of-lhe-art treatment for your advanced arthritis and ib associated 
pain. Should a scientifically proven better treatment arise during (he course of this 
study, it may be incorporated into yon cj\tc. 
NEW INFORM ATI ON 
If new information, cither good or bad, about this treatment comes to the 
ftltcnlion of the investigators during the course of this study which may be related to 
your willingness to participate, it will be provided to you 01 your representative. 
Patient Initials 
Recombinant DNA Research, Volume 19 
[4451 
