Advice on the threshold value of free viral particles in clinical studies available in English
COGEM has published an English translation of her advice on amending the threshold value of free viral particles in clinical studies with ex vivo transduced cells.
In certain gene therapies, cells from the patient are genetically modified outside the body, often using retroviral or lentiviral vector particles. When the cells are returned to the patient the vector particles are mostly washed away, but some may remain. The presence of these vector particles poses a potential risk if third parties are accidentally exposed to them. COGEM has previously recommended a threshold value for the number of vector particles allowed to be present in the cells, as a basis for determining whether or not additional measures are needed to minimize the risk of exposure to vector particles. In this advice, COGEM evaluates this threshold value and proposes amending it.
Read the advisory report here: Advice Reassessment of the threshold values for the presence of free lentiviral and retroviral vector particles in clinical trials with ex vivo transduced cells