Literature DB >> 31910049

The National Gene Vector Biorepository: Eleven Years of Providing Resources to the Gene Therapy Community.

Kenneth Cornetta1,2, Lorraine Matheson1, Ryan Long3, Lisa Duffy1.   

Abstract

The National Gene Vector Biorepository (NGVB) program has been highly accessed by gene therapy investigators. The reagent repository has distributed over 1,000 reagents to 397 investigators. The Pharmacology/Toxicology Archive contains over 36,000 specimens from a variety of adeno-associated virus (AAV), adenoviral, and other pharmacology/toxicology studies. NGVB also maintains a searchable database of gene therapy pharmacology/toxicology studies to promote data sharing. NGVB has provided Food and Drug Administration (FDA)-mandated replication-competent virus testing for over 70 clinical trials. From 2008 to 2018, there have been 114 publications acknowledging the NGVB. It is unlikely that any other National Institutes of Health (NIH)-funded program has served as many gene therapy investigators as the NGVB.

Keywords:  FDA required testing; Pharm/Tox studies; gene therapy resources; reagent repository

Mesh:

Year:  2020        PMID: 31910049      PMCID: PMC7047076          DOI: 10.1089/hum.2019.317

Source DB:  PubMed          Journal:  Hum Gene Ther        ISSN: 1043-0342            Impact factor:   5.695


  11 in total

1.  Supplemental guidance on testing for replication-competent retrovirus in retroviral vector-based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors.

Authors: 
Journal:  Hum Gene Ther       Date:  2001-02-10       Impact factor: 5.695

2.  Certification assays for HIV-1-based vectors: frequent passage of gag sequences without evidence of replication-competent viruses.

Authors:  Lakshmi Sastry; Yi Xu; Terry Johnson; Kunal Desai; David Rissing; Jonathan Marsh; Kenneth Cornetta
Journal:  Mol Ther       Date:  2003-11       Impact factor: 11.454

3.  Physical and infectious titers of helper-dependent adenoviral vectors: a method of direct comparison to the adenovirus reference material.

Authors:  Donna J Palmer; Philip Ng
Journal:  Mol Ther       Date:  2004-10       Impact factor: 11.454

4.  Absence of Replication-Competent Lentivirus in the Clinic: Analysis of Infused T Cell Products.

Authors:  Kenneth Cornetta; Lisa Duffy; Cameron J Turtle; Michael Jensen; Stephen Forman; Gwendolyn Binder-Scholl; Terry Fry; Anne Chew; David G Maloney; Carl H June
Journal:  Mol Ther       Date:  2017-09-12       Impact factor: 11.454

5.  Infection of human cells with murine amphotropic replication-competent retroviruses.

Authors:  K Cornetta; N Nguyen; R A Morgan; D D Muenchau; J W Hartley; R M Blaese; W F Anderson
Journal:  Hum Gene Ther       Date:  1993-10       Impact factor: 5.695

6.  Safety testing for replication-competent retrovirus associated with gibbon ape leukemia virus-pseudotyped retroviral vectors.

Authors:  J Chen; L Reeves; K Cornetta
Journal:  Hum Gene Ther       Date:  2001-01-01       Impact factor: 5.695

7.  Correction of X-linked chronic granulomatous disease by gene therapy, augmented by insertional activation of MDS1-EVI1, PRDM16 or SETBP1.

Authors:  Marion G Ott; Manfred Schmidt; Kerstin Schwarzwaelder; Stefan Stein; Ulrich Siler; Ulrike Koehl; Hanno Glimm; Klaus Kühlcke; Andrea Schilz; Hana Kunkel; Sonja Naundorf; Andrea Brinkmann; Annette Deichmann; Marlene Fischer; Claudia Ball; Ingo Pilz; Cynthia Dunbar; Yang Du; Nancy A Jenkins; Neal G Copeland; Ursula Lüthi; Moustapha Hassan; Adrian J Thrasher; Dieter Hoelzer; Christof von Kalle; Reinhard Seger; Manuel Grez
Journal:  Nat Med       Date:  2006-04-02       Impact factor: 53.440

8.  LMO2-associated clonal T cell proliferation in two patients after gene therapy for SCID-X1.

Authors:  S Hacein-Bey-Abina; C Von Kalle; M Schmidt; M P McCormack; N Wulffraat; P Leboulch; A Lim; C S Osborne; R Pawliuk; E Morillon; R Sorensen; A Forster; P Fraser; J I Cohen; G de Saint Basile; I Alexander; U Wintergerst; T Frebourg; A Aurias; D Stoppa-Lyonnet; S Romana; I Radford-Weiss; F Gross; F Valensi; E Delabesse; E Macintyre; F Sigaux; J Soulier; L E Leiva; M Wissler; C Prinz; T H Rabbitts; F Le Deist; A Fischer; M Cavazzana-Calvo
Journal:  Science       Date:  2003-10-17       Impact factor: 47.728

9.  Gene therapy for Wiskott-Aldrich syndrome--long-term efficacy and genotoxicity.

Authors:  Christian Jörg Braun; Kaan Boztug; Anna Paruzynski; Maximilian Witzel; Adrian Schwarzer; Michael Rothe; Ute Modlich; Rita Beier; Gudrun Göhring; Doris Steinemann; Raffaele Fronza; Claudia Regina Ball; Reinhard Haemmerle; Sonja Naundorf; Klaus Kühlcke; Martina Rose; Chris Fraser; Liesl Mathias; Rudolf Ferrari; Miguel R Abboud; Waleed Al-Herz; Irina Kondratenko; László Maródi; Hanno Glimm; Brigitte Schlegelberger; Axel Schambach; Michael Heinrich Albert; Manfred Schmidt; Christof von Kalle; Christoph Klein
Journal:  Sci Transl Med       Date:  2014-03-12       Impact factor: 17.956

10.  Screening Clinical Cell Products for Replication Competent Retrovirus: The National Gene Vector Biorepository Experience.

Authors:  Kenneth Cornetta; Lisa Duffy; Steven A Feldman; Crystal L Mackall; Marco L Davila; Kevin J Curran; Richard P Junghans; Jean Yuh Tang; James N Kochenderfer; Roisin O'Cearbhaill; Gary Archer; Hans-Peter Kiem; Nirali N Shah; Cindy Delbrook; Rosie Kaplan; Renier J Brentjens; Isabelle Rivière; Michel Sadelain; Steven A Rosenberg
Journal:  Mol Ther Methods Clin Dev       Date:  2018-08-17       Impact factor: 6.698

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