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  • 20-05-2025

    Advice Reassessment of the threshold values for the presence of free lentiviral and retroviral vector particles in clinical trials with ex vivo transduced cells

    In certain gene therapies, cells from the patient are genetically altered outside the...

    Advisory reports
    CGM/250520-01 View more
  • 14-05-2025

    Joint open letter COGEM and ZKBS on the ERA of new vaccine developments based on samRNAs and VRPs

    In this Joint open letter to the European Commission, the Netherlands Commission on G...

    Policy reports
    CGM/250514-01 View more
  • 18-10-2024

    The Value of Gene Therapy. A study of the growth, cost and accessibility of gene therapy products

    In this policy report COGEM explores how many gene therapies are in the development p...

    Policy reports
    CGM/240624-01 View more
  • 07-05-2020

    Generic environmental risk assessment of gene therapies that use GM cells containing free lentiviral particles

    A generic environmental risk assessment has been prepared for gene therapy trials in ...

    Advisory reports
    CGM/200507-01 View more
  • 11-02-2020

    Generic environmental risk assessment of clinical trials with AAV vectors

    Hundreds of clinical trials have been carried out worldwide in which use was made of ...

    Advisory reports
    CGM/190905-01 View more
  • 27-02-2019

    Immunotherapy with genetically modified T cells: unintended exposure and potential risks

    The amount of research into genetically modified (GM) T cell cancer therapies has bee...

    Policy reports
    CGM/190227-01 View more
  • 16-03-2018

    Generic advice on containment levels for replication-deficient adenoviral vector systems

    Vector systems based on adenoviruses are frequently used in biomedical research. In r...

    Advisory reports
    CGM/180316-01 View more
  • 04-09-2015

    Research report Assessment of preclinical gene therapy studies worldwide

    Frequently, the success of preclinical gene therapy studies in animal models is repor...

    Research reports
    CGM 2015-03 View more
  • 12-01-2011

    Replication-competent non-human viruses for use in clinical gene therapy: an inventory study

    All living organisms are exposed to viruses. In general, viruses infect only a single...

    Research reports
    CGM 2010-10 View more
  • 29-11-2010

    International medical tourism from the Netherlands for gene therapy

    The Netherlands Commission on Genetic Modification (COGEM) commisioned a study to the...

    Research reports
    CGM 2010-07 View more
  • 26-10-2010

    Gene therapy with naked DNA: Potential steps towards deregulation

    Naked DNA or plasmid DNA (defined in this report as pDNA administered via a non-viral...

    Research reports
    CGM 2010-06 View more