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W. French Anderson Papers 1977-1995
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Box | Folder Title
 
Series 2: Human Gene Therapy Research, 1977-1992 [series]:
 
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
 
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
 
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
2 6
Cornetta - old data, 1988-1989
2 15
Ken Cornetta RAC mat., 23 November 1988
2 7
TIL notes, 1988-1989
2 8
Pre-Kuntz, 1989
2 9
Tests for FDA certification, 1989
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
 
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
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
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
4 1
IND 3042 - N2 transduced TIL - amendments (cont'd), 1988-1989
4 2
IND 3042 - N2 transduced TIL - amendments, 1989-1990
4 3
Patent: TIL, 1989-1990
 
Forms [subseries]:
4 4
Forms, c.1989
4 5
TIL protocol checklists, c.1989
4 6
Clinical research project - forms, c.1989
4 7
Informed consent statement for HIV blood testing - form, c.1989
 
Related Material [subseries]:
4 8
"Grand Rounds - A Gene Transfer Experiment in Humans: One Year Later" - Clinical Center News, May 1990
4 9
Visit of Mrs. Arlene Holen, Associate Director for Human Resources, Veterans and Labor, OMB to NIH - itinerary, 25 August 1988
 
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