|
Box | Folder
|
Title
|
| |
Adenosine Deaminase (ADA) Human Gene Therapy
[subseries]:
|
| |
Correspondence
[subseries]:
|
| 4 |
10 |
Note to Dr. Anderson from Ken Cornetta,
1990
|
| 4 |
11-13 |
Correspondence,
1990-1991
|
| |
Protocols and Review Process
[subseries]:
|
| 4 |
14 |
Clin. protocol,
1985
|
| 4 |
15 |
Transduction safety protocol,
c.1989
|
| 4 |
16 |
Articles submitted with human gene therapy protocol - list,
c.1989
|
| 4 |
17 |
Clin. prot - ADA,
1989
|
| 4 |
18 |
Recombinant DNA Advisory Committee meeting - mailings,
6 October 1989
|
| 4 |
19 |
ADA gene therapy protocol,
1990
|
| 4 |
20-21 |
Recombinant DNA Advisory Committee meeting - mailings,
5 February 1990
|
| 4 |
22-23 |
NCI IRB - ADA,
February-March 1990
|
| 4 |
24 |
NIH IBC - ADA,
7 March 1990
|
| 4 |
25 |
NHLBI IRB - ADA,
March-July 1990
|
| 4 |
26 |
Submission of ADA Human Gene Therapy Clinical Protocol,
13 March 1990
|
| 4 |
27 |
Protocol impact analysis,
23 March 1990
|
| 4 |
28 |
Response to reviews of Human Gene Therapy Subcommittee,
29 March 1990
|
| 4 |
29 |
Human Gene Therapy Subcommittee meeting - agenda,
30 March 1990
|
| 4 |
30 |
Human Gene Therapy Subcommittee - meeting - mailing,
30 March 1990
|
| 4 |
31 |
Review of human gene therapy protocol - Wivel,
25 April 1990
|
| 4 |
32 |
Review of human gene therapy protocol - Blaese,
27 April-23 May 1990
|
| 4 |
33 |
Secondary review of clinical protocol for human gene therapy - by James F. Childress,
16 May 1990
|
| 4 |
34 |
Human Gene Therapy Subcommittee - meeting - mailings,
1 June 1990
|
| 4 |
35-36 |
Human Gene Therapy Subcommittee - meeting,
1 June 1990
|
| 4 |
37-38 |
Clinical research project - Treatment of SCID due to ADA deficiency with autologous lymphocytes transduced with a human ADA gene,
6 July 1990
|
| 4 |
39 |
Response to: Points to consider in the design and submission of protocols for the transfer of recombinant DNA into the genome of human subjects,
6 July 1990
|
| 4 |
40 |
Treatment of severe combined immunodeficiency disease (SCID) due to adenosine deaminase deficiency (ADA) with autologous lymphocytes transduced with a human ADA gene - Clinical Center hospital impact statement,
6 July 1990
|
| 4 |
41 |
Human Gene Therapy Subcommittee - meetings - mailings,
30-31 July 1990
|
| 5 |
1 |
Human Gene Therapy Subcommittee - meetings - mailings (cont'd),
30-31 July 1990
|
| 5 |
2 |
HGTS and RAC meetings - additional materials,
1990
|
| 5 |
3 |
FDA's questions,
1990
|
| 5 |
4 |
Copies of tumor letter for WFA, RBB, SAR,
1990
|
| 5 |
5-6 |
Amendment to ADA human gene therapy protocol - 90-C-195,
1992
|
| 5 |
7 |
Gene therapy protocols - book #1 [photocopy],
1991
|
| 5 |
8 |
Gene therapy protocols - book #3 [photocopy],
1992-1993
|
| 5 |
9 |
Gene therapy protocols - book #4 [photocopy],
1993
|
| |
Data - research and experimental
[subseries]:
|
| 5 |
10 |
ADA starch protocols and papers [photographs],
1985-1986
|
| 5 |
11 |
Monkey data / safety exps,
1985-1987
|
| 5 |
12 |
Long-term follow-up - yearly examination criteria,
c.1988
|
| 5 |
13 |
Monkey data,
1986-1991
|
| 5 |
14-16 |
Cellulose acetate ADA analysis,
1987-1990
|
| 5 |
17 |
FA freezer,
1990-1992
|
| 5 |
18-19 |
FA lab book,
c.1991
|
| 5 |
20 |
Tumor in LNL6 safety mouse,
1 March 1990
|
| 5 |
21 |
Hematology report,
6 March 1990
|
| 5 |
22 |
Blood chemistry report,
6 March 1990
|
| 5 |
23 |
List of samples for cellulose acetate ADA assay,
24 March 1990
|
| 5 |
24 |
DeSilva proliferation summary,
5 September-20 December 1990
|
| 5 |
25 |
Certificate of analysis - transduced T cells ,
14 September 1990
|
| 5 |
26 |
Certificate of analysis - vector supernate,
14 September 1990
|
| 5 |
27 |
TNF,
January-26 April 1991
|
| 5 |
28 |
Certificate of analysis - LASN vector supernate,
18 January 1991
|
| 5 |
29 |
Using NPTII Ab to detect gene transfer by retrovirus - and other data,
28 February-7 May 1991
|
| 5 |
30 |
ADA,
28 May 1991
|
| 5 |
31 |
In vitro proliferation results - proliferation assay - for DeSilva and Cutshall,
June-August 1991
|
| 5 |
32 |
Research data,
23 July-23 August 1991
|
| |
Investigational New Drugs (IND)
[subseries]:
|
| 5 |
33 |
IND 3624 - Human adenosine deaminase gene transduced autologous T. Lymphocytes,
1990
|
| 5 |
34 |
IND 3624 - Autologous lymphocytes transduced with human adenine deaminase gene (retrovirus vector LASN) cultivated with IL-2 (cetus) and ORT3 (ortho),
1991
|
| 5 |
35 |
Human adenosine deaminase gene transduced autologous T-lymphocytes (ADA-transduced T lymphocytes) - annual report to FDA,
1991
|
| |
Forms
[subseries]:
|
| 5 |
36 |
Treatment of severe combined immunodeficiency disease (SCID) due to adenosine deaminase deficiency (ADA) with autologous lymphocytes transduced with a human ADA gene - patient consent form,
c.1990
|
| 5 |
37 |
Children's assent form [for ADA-SCID protocol],
c.1990
|
| 5 |
38 |
GTI supernatant request form,
1990
|
| |
Scheduling and Procedures
[subseries]:
|
| 5 |
39 |
Information for ADA-SCID gene therapy patients - drafts,
1990
|
| 5 |
40 |
Selection of ADA-SCID patients,
1990
|
| 5 |
41 |
DeSilva patient name labels,
1990
|
| 5 |
42 |
DeSilva schedule,
1990
|
| 5 |
43 |
Cindy Cutshall - schedule,
1990
|
| 5 |
44 |
Rainbow patients are first candidates for new gene transplants - news release,
2 August 1990
|
| 5 |
45 |
Schedule for A.D. and her family,
3-7 September 1990
|
| 5 |
46 |
Dr. Anderson [photographs],
13-14 September 1990
|
