ReviewMolecular therapy. Methods & clinical development2025
Risks of replication-competent retro/lentivirus from associated vector systems: Is it time for a roadmap toward reduced testing?
Review in Molecular therapy. Methods & clinical development, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
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.
Who cites it
3 citing papers in PubMed.
- Article
- Enhanced transcriptional insulation of lentiviral vectors using "sequence-upgraded polyA long terminal repeats" or "supA-LTRs".Molecular therapy. Advances · 2026Article
- Gammaretrovirus Infections in Humans in the Past, Present, and Future: Have We Defeated the Pathogen?Pathogens (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The development of retroviral and lentiviral vectors (RV/LVs) has culminated in third-generation vector systems with excellent safety profiles. However, there has been no significant (re)assessment of RCR/RCL formation risk within RV/LV systems regarding the underlying molecular recombination events, despite updated guidance for RCR/RCL assay development/testing issued by the key regulatory agencies. This review reflects on genuine RCRs generated in early vector systems that drove the development of the common safety features of all third-generation systems. We then present a "minimal-path" model for RCL formation within four-component LV systems, which draws on published recombination rates between plasmid DNA in cell lines and retrovirus genomic RNA during reverse transcription. This model indicates that the probability of generating a single RCL genome molecule at 200-L scale is ≤ 1 in 10,000 per bioreactor and is reduced by 100-fold if packaging cell lines containing integrated vector components are used. We propose that the improbability of generating RCR/RCL within contemporary vector systems justifies consideration of a roadmap to reduced testing and provide potential aspects of such a roadmap for the field to contemplate. We also review past and current guidelines for RCL testing and assay development, recommending key aspects of method development toward unification in the field.
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Registered trials
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.