RECOMBINANT DNA ADVISORY COMMITTEE (RAC) 
DATA MANAGEMENT REPORT - DECEMBER 1993* 
Status 
(Open/ 
Closed) 
c 
£ 
Open 
Open 
Closed 
■o 
i 
0 
Qosed 
Qosed 
Open 
Open 
Open 
Open 
Open 
# 
Deaths 
• 
o 
00 
■<r 
o 
- 
7-3 
trans- 
planted 
a. 
- 
o 
< 
Effects 
No 
No 
1 - 
transient 
eleva- 
tion of 
liver 
function 
No 
No 
No 
ND-1 
patient 
failed to 
engraft 
fr- 
No 
No 
No 
No 
Problems 
with Gene 
Transfer 
No 
No 
No 
No 
No 
No 
No 
C- 
No 
No 
No 
No 
> 
iv. 
Evidence 
of Gene 
Transfer 
(Human) 
Yes 
Yes 
Yes 
Yes 
Yes 
3 
>• 
Yes 
fra 
Yes 
Yes 
Yes 
Yes 
Patient 
Accrual 
To 
Date 
2 
2- PBL 
1-PBSC 
3- CBSC 
N 
10 
entered/ 
5 trans- 
planted 
o 
XT 
CO 
Maximum 
Patient 
Accrual 
Unlimited 
o 
8 
<N 
© 
o 
o 
o 
8 
»o 
VO 
t 
Supplier 
LLO 
GTI 
GTI 
GTI/ 
Chiron 
LID 
GTI 
GTI 
LID 
GTI 
GTI 
GTI/ 
Chiron 
LID 
U. of PA 
Packag- 
ing Cell 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
Y-crip 
t 
> 
Gene 
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t> 
Z 
< 
< O O 
5 5 
X 
o 
6 
Z 
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z 
5 
* 
o 
o 
5. 
<0 
Z 
o 
* 
o 
V 
n 
Z 
5 
* 
o 
o 
Z 
5 
* 
o 
o 
Z 
* 
o 
o 
Z 
* 
8 
z 
<N 
§ 
z 
5 
CMV-BA- 
(h)LDLR 
Date 
First 
Patient 
Treated 
5-22-89 
9-14-90 
5-13-93 
1-29-91 
9-9-91 
1-27-92 
1-16-92 
7-31-92 
fra 
8 
A 
£ 
t 
8 
2 
6-5-92 
Patients 
Cancer 
SCID 
(ADA- 
defic.) 
Cancer 
BMM/ 
AML 
BMM/ 
NBL 
Cancer/ 
NBL 
BMM/ 
CML 
Acute 
Hepatic 
Failure 
Cancer/ 
Melanoma 
Cancer 
Cancer 
FH 
M/T 
h 
H 
H 
2 
2 
2 
2 
2 
2 
H 
r 
H 
N1H 
Approval 
Date 
r 
8 "8 
t § 
9-6-90 
7-12-91 
7-12-91 
7-12-91 
7-12-91 
7-12-91 
1-17-92 
10-15-91 
10-15-91 
11-14-91 
RAC 
Approval 
Date 
s 
6 
7-31-90 
2-10-92 b 
7-31-90 
£ 
(N 
5-31-91 
5-31-91 
5-31-91 
5-30-91 
5-30-91 
10-7-91 
10-7-91 
10-8-91 
Institution 
NIH 
NIH 
NIH 
St. Jude 
St. Jude 
St. Jude 
MD 
Anderson 
Bayior 
U. of 
Pittsburgh 
NIH 
NIH 
U. of PA 
3 . 
flu 
Rosenberg 
Blaese 
Rosenberg 
Brenner, et 
al. 
u 
V ^ 
C 1 
t 
a 
Brenner, et. 
al. 
Deisseroth 
Ledley, 
et. al. 
Lotzc 
Rosenberg 
E? 
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1 
Wilson 
a 
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> 
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9007-003 
9102-004® 
9105-005® 
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9105-007® 
9105-008 
9105-009® 
9110-010® 
II0-0IX6 
9110-012® 
[ 582 ] 
Recombinant DNA Research, Volume 18 
