Thepreparation of such radiopharmaceuticals using Technetium generators isconsidered to be manufacture and so an MIA(IMP) would be required if they wereto be used as IMPs. Note that the Clinical Trial Regulations define aninvestigational medicinal product (including a licenced medicinal product) asbein...
“Taking into consideration that the cells represent a unique and distinct cell population in comparison to standard MSCs and that unique functionality is claimed,in vitro functional data with the product are needed to establish the (additional) mode(s) of action relevant for the therapeut...