ReviewHuman gene therapy methods2017
A Guide to Approaching Regulatory Considerations for Lentiviral-Mediated Gene Therapies.
Review in Human gene therapy methods, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 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
48 citing papers in PubMed, 96 citations in OpenAlex.
- Exosome Nanotechnology in Molecular Medicine Advances, Applications and Challenges in Gene Therapy.Expert reviews in molecular medicine · 2026Review
- Optimizing In Vivo CAR T-cell Engineering for Cancer Immunotherapy.Cancer research · 2026Review
- Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU.Frontiers in medicine · 2026Review
- Review
- CAR T cell engineering impacts antigen-independent activation and co-inhibition.Molecular therapy. Methods & clinical development · 2025Article
- Article
- Barriers and solutions for CAR-T therapy in solid tumors.Cancer gene therapy · 2025Review
- Lentiviral Vectors: From Wild-Type Viruses to Efficient Multi-Functional Delivery Vectors.International journal of molecular sciences · 2025Review
- 3D models to study therapy-induced senescence: where do we stand now?Cytotechnology · 2025Review
- Navigating the Purification Process: Maintaining the Integrity of Replication-Competent Enveloped Viruses.Vaccines · 2025Review
- From ex vivo to in vivo chimeric antigen T cells manufacturing: new horizons for CAR T-cell based therapy.Journal of translational medicine · 2025Review
- Gene Editing for Duchenne Muscular Dystrophy: From Experimental Models to Emerging Therapies.Degenerative neurological and neuromuscular disease · 2025Review
- RNA Structure: Past, Future, and Gene Therapy Applications.International journal of molecular sciences · 2024Review
- Nanoparticle Targeting Strategies for Lipid and Polymer-Based Gene Delivery to Immune Cells In Vivo.Small science · 2024Article
- Advancements in Nanoporous Materials for Biomedical Imaging and Diagnostics.Journal of functional biomaterials · 2024Review
- Gene therapy for CNS disorders: modalities, delivery and translational challenges.Nature reviews. Neuroscience · 2024Review
- A solution for highly efficient electroporation of primary cytotoxic T lymphocytes.BMC biotechnology · 2024Article
- Recent developments in gene therapy research in India.Journal of biosciences · 2024Review
- Universal ddPCR-based assay for the determination of lentivirus infectious titer and lenti-modified cell vector copy number.Molecular therapy. Methods & clinical development · 2023Article
- Lentiviral delivered aflibercept OXB-203 for treatment of neovascular AMD.Molecular therapy. Methods & clinical development · 2023Article
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 at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Lentiviral vectors are increasingly the gene transfer tool of choice for gene or cell therapies, with multiple clinical investigations showing promise for this viral vector in terms of both safety and efficacy. The third-generation vector system is well characterized, effectively delivers genetic material and maintains long-term stable expression in target cells, delivers larger amounts of genetic material than other methods, is nonpathogenic, and does not cause an inflammatory response in the recipient. This report aims to help academic scientists and regulatory managers negotiate the governance framework to achieve successful translation of a lentiviral vector-based gene therapy. The focus is on European regulations and how they are administered in the United Kingdom, although many of the principles will be similar for other regions, including the United States. The report justifies the rationale for using third-generation lentiviral vectors to achieve gene delivery for in vivo and ex vivo applications; briefly summarizes the extant regulatory guidance for gene therapies, categorized as advanced therapeutic medicinal products (ATMPs); provides guidance on specific regulatory issues regarding gene therapies; presents an overview of the key stakeholders to be approached when pursuing clinical trials authorization for an ATMP; and includes a brief catalogue of the documentation required to submit an application for regulatory approval of a new gene therapy.
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.