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Box | Folder
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Title
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Series 2: Human Gene Therapy Research,
1977-1992 [series]:
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Tumor-Infiltrating Lymphocytes (TIL)/Marker Gene
[subseries]:
|
| |
Correspondence
[subseries]:
|
| 1 |
4 |
FDA,
1984-1988
|
| 1 |
5 |
Correspondence,
1988-1989
|
| 1 |
6 |
Correspondence,
1989
|
| 1 |
7 |
FDA review of protocol IND 3042,
1989
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| |
Protocols and Review Process
[subseries]:
|
| 1 |
8 |
Bone marrow - protocols and data,
1986-1987
|
| 1 |
9 |
Animal protocols for baboons, cynomologous monkeys, and rhesus monkeys,
1987-1989
|
| 1 |
10-14 |
Human gene therapy preclinical data summary - to Human Gene Therapy Subcommittee,
24 April 1987
|
| 1 |
15 |
FDA duplicates,
1989
|
| 1 |
16 |
SAR notes,
April-November 1989
|
| 1 |
17 |
N2/TIL,
7 August 1989
|
| 1 |
18-19 |
FDA Adv. Comm [FDA advisory committee],
19 December 1988
|
| 1 |
20 |
Human Gene Therapy Subcommittee - meeting,
31 July 1989
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| |
Data
[subseries]:
|
| 1 |
21 |
Half life of TIL in circulating blood,
c.1980s
|
| 1 |
22-25 |
Southerns / probes / food / misc. molecular biology,
1985-1987
|
| 2 |
1-4 |
TIL notebooks,
1985-1989
|
| 2 |
5 |
CFU - Media Record I - SB 7D17,
1986-1988
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| 2 |
6 |
Cornetta - old data,
1988-1989
|
| 2 |
15 |
Ken Cornetta RAC mat.,
23 November 1988
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| 2 |
7 |
TIL notes,
1988-1989
|
| 2 |
8 |
Pre-Kuntz,
1989
|
| 2 |
9 |
Tests for FDA certification,
1989
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| 2 |
10 |
Certification of analysis - TIL,
1989
|
| 2 |
11 |
Certificate of analysis - viral supernate and N2 viral supernate,
1989
|
| 2 |
12 |
TIL protocol,
1988
|
| 2 |
13 |
FDA-NCI audit,
1989
|
| 2 |
14 |
Clin. Prot. - TIL,
1990
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| |
Investigational New Drugs (IND)
[subseries]:
|
| 2 |
16-17 |
Study 86-C-183 - IND 1969 - The treatment of patients with advanced cancer using high dose recombinant interleukin-2 plus cyclophosphamide and TIL - clinical research project annual review,
1988-1989
|
| 2 |
18-20 |
IND 2474 - N2 transduced TIL - original filing book II,
1987
|
| 2 |
21-23 |
IND 2474 - N2 transduced TIL - original filing book I,
1988
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| 3 |
1-3 |
IND 2474 - N2 transduced TIL - original filing book I,
1988
|
| 3 |
4-5 |
Murine monoclonal antibodies to tumor associated glycoprotein (TAG-72),
1988
|
| 3 |
6-8 |
IND 3042 - N2 transduced TIL - original filing - book I,
1988
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| 3 |
9 |
IND 3042 for N2 transduced TIL cells,
1989
|
| 3 |
10-11 |
IND 3042 - N2 transduced TIL,
1989
|
| 3 |
12-14 |
IND 3042 - N2 transduced TIL - FDA duplicates,
1988-1989
|
| 3 |
15-17 |
IND 3042 - N2 transduced TIL - summary,
1988-1989
|
| 3 |
18-19 |
IND 3042 - N2 transduced TIL - amendments,
1988-1989
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| 4 |
1 |
IND 3042 - N2 transduced TIL - amendments (cont'd),
1988-1989
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| 4 |
2 |
IND 3042 - N2 transduced TIL - amendments,
1989-1990
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| 4 |
3 |
Patent: TIL,
1989-1990
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| |
Forms
[subseries]:
|
| 4 |
4 |
Forms,
c.1989
|
| 4 |
5 |
TIL protocol checklists,
c.1989
|
| 4 |
6 |
Clinical research project - forms,
c.1989
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| 4 |
7 |
Informed consent statement for HIV blood testing - form,
c.1989
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Related Material
[subseries]:
|
| 4 |
8 |
"Grand Rounds - A Gene Transfer Experiment in Humans: One Year Later" - Clinical Center News,
May 1990
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| 4 |
9 |
Visit of Mrs. Arlene Holen, Associate Director for Human Resources, Veterans and Labor, OMB to NIH - itinerary,
25 August 1988
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| |
Adenosine Deaminase (ADA) Human Gene Therapy
[subseries]:
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| |
Correspondence
[subseries]:
|
| 4 |
10 |
Note to Dr. Anderson from Ken Cornetta,
1990
|
| 4 |
11-13 |
Correspondence,
1990-1991
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| |
Protocols and Review Process
[subseries]:
|
| 4 |
14 |
Clin. protocol,
1985
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| 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
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| 4 |
24 |
NIH IBC - ADA,
7 March 1990
|
| 4 |
25 |
NHLBI IRB - ADA,
March-July 1990
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| 4 |
26 |
Submission of ADA Human Gene Therapy Clinical Protocol,
13 March 1990
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| 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
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| 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
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| 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
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| |
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
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| 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
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| |
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
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| |
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
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| |
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
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