Evidence map›Paper›PMID 21083425›Full record

ArticleHuman gene therapy2011

Current good manufacturing practice production of an oncolytic recombinant vesicular stomatitis viral vector for cancer treatment.

L J Ausubel, M Meseck, I Derecho, P Lopez, C Knoblauch, R McMahon, J Anderson, N Dunphy, V Quezada, R Khan and 6 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Human gene therapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
1.5field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 32 citations in OpenAlex.

  1. Review
  2. Article
  3. Characterization of VSV-GP morphology by cryo-EM imaging and SEC-MALS.Molecular therapy. Methods & clinical development · 2025
    Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Evaluation of vesicular stomatitis virus mutant as an oncolytic agent against prostate cancer.International journal of clinical and experimental medicine · 2014
    Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 1 institution in 1 country.

L J AusubelCenter for Biomedicine and Genetics, and Center for Applied Technology Development, Beckman Research Institute of City of Hope, Duarte, CA 91010, USA. lausubel@coh.org
M Meseck
I Derecho
P Lopez
C Knoblauch
R McMahon
J Anderson
N Dunphy
V Quezada
R Khan
P Huang
W Dang
M Luo
D Hsu
S L C Woo
L Couture
Icahn School of Medicine at Mount Sinai · US

Funding

Phase I Clinical Translation Trial of Oncolytic rVSV-F Virotherapy for HCCR01CA120372 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI WOO, SAVIO L · 2006 to 2010
$2.8M
NCI NIH HHS 1R01CA120372
6 · The paper itself

Abstract

Vesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 10(9) plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 10(10) PFU/ml (total yield, 1 × 10(13) PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC.

Indexed as

Genetic VectorsOncolytic VirotherapyVesicular stomatitis Indiana virusAnimalsBiotechnologyCell Culture TechniquesCell LineChromatography, Ion ExchangeCricetinaeHEK293 CellsHumansNeoplasmsUltrafiltration

Identifiers

PMID21083425
PMCPMC3073073
OpenAlexW2052949542

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.