This commentary discusses regulatory concerns around allogeneic cell product use in individual protocols, suggesting the need for clearer criteria.
This brief commentary addresses aspects of the handling and use of cell products under individual treatment protocols. It highlights two potentially controversial issues: (1) the potential use of the individual pathway to administer allogeneic products without regulatory approval, and (2) the lack of well-defined regulatory criteria in this field.
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P. I. Makarevich (2026) studied this question.
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