Translation of advice on the updated preconditions for clinical studies involving ex vivo transduced cells

COGEM is working on a translation of her advice which updates the preconditions for generic environmental risk assessment of clinical studies and marketing applications involving ex vivo retro- and lentiviral transduced cells.

In 2019 and 2020, COGEM conducted generic environmental risk assessments for clinical studies involving cells that have been modified outside the body (ex vivo) using retroviral and lentiviral vectors. These assessments established preconditions that clinical studies must meet to ensure that environmental risks are negligible. These assessments also contributed to the drafting of permits under fixed conditions (VoVs) in the Netherlands. This permits such studies to be processed more quickly and easily.
Following the initial assessments, COGEM issued additional recommendations. Some preconditions were tightened or amended in line with new insights. The current advice updates the previous generic environmental risk assessments. It summarizes and explains the current preconditions for clinical studies involving the use of ex vivo retro- and lentiviral transduced cells. COGEM considers the risks to humans and the environment in such clinical studies to be negligible if these preconditions are met. COGEM recommends incorporating these updated preconditions into the VoVs.