ReviewCell reports. Medicine2025
Current regulatory requirements for assessment of immunogenicity for gene therapy medicinal products.
Review in Cell reports. Medicine, 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.
- Exosome-loaded nanoradiosensitizers in radiotherapy for preventing post-irradiation tumor recurrence: mechanisms, preclinical evidence, and translational challenges.Discover nano · 2026Review
- Beyond CRISPR: next-gen precision engineering of CAR-NK cells for enhanced persistence, trafficking, and tumor eradication.Cancer cell international · 2026Review
- Gene modification: Exploring the potential in treating kidney diseases.Pharmacological research · 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
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Gene therapy medicinal products (GTMPs) are currently undergoing intense industrial expansion and technological advancement. However, one issue facing development of most GTMPs is the generation of unwanted immune responses. Immunomodulatory strategies are also often applied in conjunction with GTMP administration to suppress or enhance these responses. This review focusses on the global regulatory requirements for immunogenicity assessments and immunomodulation in relation to GTMPs. The specific aims are to (1) identify the principal international guidelines; (2) identify areas of concordance and discrepancy between guidelines; (3) propose areas where guidelines could be harmonized; and (4) predict areas, which future guidance may address. Methodologies used included surveillance of literature, international guidelines, advocacy initiatives, and compilation of previous regulatory advice received. Overall, there is a clear absence of and need for GTMP-specific guidance on immunogenicity and immunomodulation. Several specific measures and areas for future regulatory harmonization and coverage are proposed.
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.