Evidence map›Paper›PMID 37171121›Full record

ArticleHuman gene therapy2023

Assessment of Residual Full-Length SV40 Large T Antigen in Clinical-Grade Adeno-Associated Virus Vectors Produced in 293T Cells.

Bishnu P De, Sara Cram, Hyunmi Lee, Jonathan B Rosenberg, Dolan Sondhi, Ronald G Crystal, Stephen M Kaminsky

Open access · greenAbstract read
In one paragraph

Article in Human gene therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.2field-weighted citation impact, top 12% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
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  4. Review
  5. Article
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

7 authors at 1 institution in 1 country.

Bishnu P DeDepartment of Genetic Medicine, Weill Cornell Medicine, New York, New York, USA.
Sara CramDepartment of Genetic Medicine, Weill Cornell Medicine, New York, New York, USA.
Hyunmi LeeDepartment of Genetic Medicine, Weill Cornell Medicine, New York, New York, USA.
Jonathan B RosenbergDepartment of Genetic Medicine, Weill Cornell Medicine, New York, New York, USA.
Dolan SondhiDepartment of Genetic Medicine, Weill Cornell Medicine, New York, New York, USA.ORCID 0000-0002-2218-5910
Ronald G CrystalDepartment of Genetic Medicine, Weill Cornell Medicine, New York, New York, USA.ORCID 0000-0001-6177-6839
Stephen M KaminskyDepartment of Genetic Medicine, Weill Cornell Medicine, New York, New York, USA.ORCID 0000-0003-1869-834X
Cornell University · US

Funding

Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
Phase IA/IB Study of AAVrh.10hFXN Therapy to Treat the Cardiomyopathy of Friedreich's AtaxiaR33HL151355 · NHLBI · WEILL MEDICAL COLL OF CORNELL UNIV · PI CRYSTAL, RONALD G, KAMINSKY, STEPHEN MICHAEL · 2022 to 2024
$5.9M
Phase IA/IB Study of AAVrh.10hFXN Therapy to Treat the Cardiomyopathy of Friedreich's AtaxiaR61HL151355 · NHLBI · WEILL MEDICAL COLL OF CORNELL UNIV · PI CRYSTAL, RONALD G, KAMINSKY, STEPHEN MICHAEL · 2020 to 2020
$420k
NCATS NIH HHS UL1 TR001873NCATS NIH HHS UL1 TR002384NHLBI NIH HHS R33 HL151355NHLBI NIH HHS R61 HL151355
6 · The paper itself

Abstract

Efficient production of adeno-associated virus (AAV) vectors is a significant challenge. Human embryonic kidney HEK293T cells are widely used in good manufacturing practice facilities, producing higher yield of AAV vectors for clinical applications than HEK293 through the addition of a constitutive expression of SV40 large T antigen (SV40T), which stimulates Rep expression. However, the theoretical potential for tumorigenic consequences of a clinical AAV product containing residual DNA encoding SV40T, which may inhibit p53 growth suppressive functions is a safety concern. Although the risk is theoretical, to assure a low risk/high confidence of safety for clinical drug development, we have established a sensitive assay for assessment of functional full-length transcription competent SV40T DNA in HEK293T cell-produced AAV vectors. Using HEK293T generated 8, 9, and rh.10 serotype AAV vectors, the presence of SV40T in purified vector was assessed

Indexed as

Herpesvirus 1, HumanAnimalsAntigens, Viral, TumorDependovirusDNAGenetic VectorsHEK293 CellsHumansMiceAntigens, Viral, TumorDNAAAVclinicalgene therapyGMP production

Identifiers

PMID37171121
PMCPMC10457653
OpenAlexW4376224209

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.