The Gene Therapy Office comes into play as soon as you want to carry out clinical gene therapy research involving human subjects.
The Gene Therapy Office comes into play as soon as you want to carry out clinical gene therapy research involving human subjects. Although there are currently various definitions of gene therapy, the Gene Therapy Office understands it to mean the following: "Clinical research in humans either involving activities with genetically modified organisms (GMO (Genetically Modified Organism)), or whereby genetically modified cells can be created in the human body, or whereby changes are made to the genetic material of human cells."
In practice this means that the Gene Therapy Office is involved in clinical studies, the following non-exhaustive list being examples:
- Vaccination studies with genetically modified viral vectors, such as adeno-associated virus (AAV (Adeno-Associated Virus)), vaccinia viruses, herpes viruses, retroviruses and lentiviruses;
- Vaccination studies with genetically modified cells, either neoplastic or non-neoplastic and either irradiated or non-irradiated;
- Vaccination studies with naked DNA or plasmid DNA;
- Ex-vivo gene therapy studies with genetically modified T cells;
- Studies with genetically modified bacteria, parasites or other organisms;
- Studies with replication-defective, conditionally replicating or replicating genetically modified viral vectors, such as adenoviruses;
- Studies with investigational medicinal products that contain a GMO.
This list of examples is intended as a guide. If you are in any doubt or if it is unclear whether your research should be submitted and assessed through the Gene Therapy Office, we recommend that you contact us.
Diagram of procedures and the position of the Gene Therapy Office.
The Gene Therapy Office was set up as of 1 October 2004 in order to streamline the various procedures of the bodies involved, to coordinate these procedures more effectively and to provide more insight into the procedures for investigators. In concrete terms this means that the Gene Therapy Office serves as a central point of contact between investigators and the assessment bodies. The Gene Therapy Office receives all applications, changes and reports; streamlines the processing where possible; and communicates decisions to the investigator. The Gene Therapy Office also serves as an information point for investigators, sponsors, the government and other interested parties.