Phase 1/2a, randomized controlled trial (NCT05626712) evaluating CELZ-201 therapy in recent-onset T1D. Primary outcome measures include safety and efficacy, assessed by changes in C-peptide during a 4-hour MMTT, HbA1c, exogenous insulin requirements, and autoantibody levels. Study duration is 24 months (66). This evidence concerns the gene INS and type 1 diabetes mellitus.