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...
“It appears it is possible that the cells may have changed to those used in the phase 2 trial in Greece, and that Heartcel product in the current trial is not the same as that used previously.However, this is only based on the entry for the phase 2 trial in Greece on Clini...