ReviewApplied biosafety : journal of the American Biological Safety Association2024
A Review of Clinical Trials Involving Genetically Modified Bacteria, Bacteriophages and Their Associated Risk Assessments.
Review in Applied biosafety : journal of the American Biological Safety Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled 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.
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
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Enabling Clinical Translation of Oral Probiotics Through Formulation Engineering and Scalable Manufacturing.Biotechnology journal · 2026Pooled it
- Systems engineering of engineered live biotherapeutics: A discovery-to-translation framework for streamlining microbiome therapeutic development.Journal of controlled release : official journal of the Controlled Release Society · 2026Review
- Bacteria-mimicking cancer cells reprogram macrophages via multiple pattern recognition receptor pathways for cancer immunotherapy.Signal transduction and targeted therapy · 2026Article
- Next-Generation Strategies for Controlling Foodborne Pathogens: Precision Antimicrobials, Biofilm Disruption, and Emerging Molecular Interventions.Foods (Basel, Switzerland) · 2026Review
- The ladder of regulatory stringency and balance: an application to the US FDA's regulation of bacterial live therapeutics.Gut microbes · 2025Review
- Evolutionary adaptation of probiotics in the gut: selection pressures, optimization strategies, and regulatory challenges.NPJ biofilms and microbiomes · 2025Review
- The Microbiome and Metabolic Dysfunction-Associated Steatotic Liver Disease.International journal of molecular sciences · 2025Review
- Engineered Bacteria for Disease Diagnosis and Treatment Using Synthetic Biology.Microbial biotechnology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: Discussion of gene-modified investigational products (IPs) in clinical trials has largely focused on nucleic acid-based vectors, viral vectors, and gene-modified cellular products involving mammalian cells. Use of bacteria and bacteriophages as IPs is resurgent, and discussion of the risks associated with genetic modification of these organisms has become pertinent to the biosafety community. Methods: This review article summarizes the United States Food and Drug Administration classification for IPs comprising bacteria or bacteriophages and provides an overview of clinical trials conducted to date involving genetically modified bacteria. The risk assessment for bacterial or bacteriophage-based IPs is discussed. Conclusion: The risk assessment process for bacterial or bacteriophage-based IPs is different from that of gene expression vectors and mammalian cells. Greater consideration must be given to the attenuating mutations affecting virulence, replication competency, antibiotic susceptibility, and persistence in the environment. With the recent growth in clinical trials involving genetically modified bacteria, biosafety professionals and Institutional Biosafety Committees with responsibilities including oversight of clinical trials must become familiar with the associated risk assessment.
Indexed as
Identifiers
What Socratic holds
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 Socratic graph.