479 
94? 5B26B it) 15^47 P.17 
fiNO 
DESCRIPTI ON 
This study is being done to see if gene lliciapy umi be used as a treatment for 
rheumatoid arthritis. We will not cure rheumatoid ai lhiltis in yuui juliils which we 
gtudy. We hope that this may be an important step towards a cure for rheumatoid 
flrthriti-« and other joint diseases. The speeifie purpose of this study is to see If we can 
piT>virle. painful joints with modified joint cavity lining colls which make more of a 
natural human joint .sub.stanre (n protein) which has been shown to decrease joint 
swelling. We have shown already that when we pul an anti-swelling protein (called 
IRAP or iiilerlcukinT receptor antagonist protein) into the knee of the rabhil. we can 
block sw'elling and wc assume, the pain which comes along with that. 
The firs', step is to put the gene for IRAH into youi cells. We gel your joint cavity 
lining cells from your joint during the removal of painful swollen joint lining tissue. Tlje 
joint which this tissue w'ould be removed from would depend on your situation. This 
procedure would be done for you whether or not you are part of this study. Usually this 
tissue is sent only to J^alhology, and much tissue is wasted. We will use the tissue, which 
is usually discarded to collect your relU and change them. We will attempt to grow your 
own cells on glass in our laboratoiy. We will attempt to change them using a weakened 
viius as a way lu deliver the IRAP gene to the genes of your cells. Many other studies 
with human.5 have sliown that these weakened viruses can be used as tools to deliver 
genes to cells in the laboratory. Because the vlius has been deliberately disabled, it is 
normally unable to make more virus, cause disease or affect you oi youi cells in any way. 
When your cells are ready (probably 1-2 months after IIjc first procedure), you will come 
back for an office visit with Dr. Herndon, as normal, to follow your progress after the 
first prorediire. During this visit. Dr. Herndon will give back your modified cells to your 
knuckle joints througli simple injertion(s). 'Ihese injections could bo painful enough to 
require local anesthetic. These are joints which yon plan to have replaced with orlifcial 
joints in one week. ITie four knuckle replacement will he undertaken one week after 
you get your changed cells back, 'flierefore, all modified cells should be removed from 
your body. ’Ilie gene tliciapy used in this study should not have a lasting effect on you 
or your disca.-^c. However, the joint tissues remove at the lime of knuckle joint 
replacement will be analyzed in the laboratory to see whether the attempt at gene 
transfer has been Eucceseful. You will be followed closely after you undergo your 
planned four knuckle joint replacement, eventually being seen every two years for the 
remainder of your lilctime. If you move or Dr. Herndon retires, your records will be 
forwarded In the phy.sirian of your choice. Of course, a referral will be given if asked 
for. 
RISKS AND BENEFITS 
1. There is a very small risk that the gene placed in yuui cells will irUerfere with 
on important gene or activate a bad gene. Tliis has never occurred in olhei studies in 
Patient Initials 
[ 444 ] 
Recombinant DNA Research, Volume 19 
