PS2: ATMP innovations and clinical trials with genetically modified organisms


Patrick Ginty focused on ‘off-the-shelf’ cell therapies from a scientific and regulatory perspective. He stressed the importance of defining the criteria, namely, cell-based therapies that are manufactured from healthy allogeneic donor with material and stored until ready for patient administration – essentially one donor to multiple recipients with no patient-donor specificity required. Conversely, we then don’t include autologous cell therapies (same donor and recipient) and allogeneic cell therapies which are donor-recipient specific, ie., anything which is Human Leucocyte Antigen-restricted (HLA) to avoid immune reaction.

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