ReviewRegenerative therapy2026
Metagenomic-driven predictive biosafety and contamination traceability in stem cell manufacturing: Translating outbreak genomics into regenerative medicine.
Review in Regenerative therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Stem cell manufacturing and regenerative medicine laboratories are highly vulnerable to microbial contamination due to complex processing workflows, extensive manipulation, prolonged culture conditions, and continuous environmental exposure. Conventional microbiological methods remain fundamental for laboratory quality control; however, they may underestimate concealed resistance determinants, microbial diversity, contamination pathways, and transmission dynamics. Recent advances in metagenomic sequencing have transformed outbreak investigation, resistome characterization, and genomic surveillance, providing unprecedented opportunities for contamination monitoring and biosafety management. This review proposes a translational biosafety framework that integrates metagenomic surveillance with contamination traceability systems in stem cell manufacturing and regenerative medicine laboratory environments. The review discusses contamination challenges, limitations of conventional microbiological diagnostics, metagenomic surveillance approaches, predictive biosafety concepts, genomic traceability systems, corrective and preventive action (CAPA) integration, and future artificial intelligence (AI)-assisted monitoring strategies. Lessons from sequencing-based outbreak investigations involving multidrug-resistant microorganisms highlight the potential utility of metagenomic surveillance for early detection of contamination, microbial source attribution, resistome characterization, environmental monitoring, and contamination traceability. Integrating sequencing-guided diagnostics with laboratory traceability systems and CAPA-based quality management may shift biosafety practices from reactive contamination control toward proactive predictive biosurveillance. The proposed framework may strengthen contamination prevention, improve manufacturing reproducibility, support regulatory compliance, and enhance the reliability of stem cell processing and regenerative medicine applications. Future studies are needed to standardize sequencing-guided biosafety workflows and evaluate their implementation in academic, research, and clinical-grade stem cell manufacturing laboratories.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.